CN101738438A - Detection method of related substances of nitrendipine and atenolol compound composition - Google Patents
Detection method of related substances of nitrendipine and atenolol compound composition Download PDFInfo
- Publication number
- CN101738438A CN101738438A CN200810236311A CN200810236311A CN101738438A CN 101738438 A CN101738438 A CN 101738438A CN 200810236311 A CN200810236311 A CN 200810236311A CN 200810236311 A CN200810236311 A CN 200810236311A CN 101738438 A CN101738438 A CN 101738438A
- Authority
- CN
- China
- Prior art keywords
- nitrendipine
- atenolol
- solution
- peak
- methyl alcohol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention provides a method for detecting related substances of a nitrendipine and atenolol compound composition through a high-efficiency liquid chromatography method. The method comprises the following steps of: detecting the related substances of atenolol in the nitrendipine and atenolol compound composition by using a gradient elution method and high-efficiency liquid chromatography, wherein a mixture of a water phase and an organic phase with a pH value of 3.0 in a certain gradient proportion is used as a mobile phase, the detection wavelength is 226nm, and the column temperature is 30 DEG C; and detecting the related substances of nitrendipine in the nitrendipine and atenolol compound composition at a column temperature of 30 DEG C by using a water phase and an organic phase as a mobile phase with a pH value of 3.0 and a detection wavelength of 235nm.
Description
Technical field
The present invention relates to medical technical field, more particularly, the present invention relates to the related substance detection method of nitrendipine and atenolol compound composition.
Background technology
Nitrendipine is a kind of bihydropyridine type calcium antagonist, to blood vessel selectivity height, and expansible coronary artery and peripheral vascular, rapid-action, safety, gentleness, lasting, the less water-sodium retention that occurs can reduce myocardial consumption of oxygen, and ischemic myocardium is had protective effect; The heart rate reflectivity can occur when heavy dose of and speed no postural hypotension; Take curative effect for a long time and do not subtract, no cumulative effect.
Atenolol belongs to selectivity β1-Shou Ti retarding agent, no intrinsic sympathomimetic acitivity, and no quinine fourth sample cardiac muscle inhibiting effect is not passed through blood-brain barrier; Be used for the treatment of hypertension, angina pectoris and arrhythmia cordis.
Nitrendipine and atenolol are made compound medicine treats hypertension, angina pectoris and arrhythmia cordis etc. and has obtained good efficacy.In the medicine production process, the content that needs related substance in the detection of drugs has good efficacy when clinical to guarantee to be used for.For nitrendipine and atenolol compound medicine, the effective ways of the related substance of these two kinds of active components need be measured in this area.
Summary of the invention
The invention provides the method that detects the related substance of nitrendipine and atenolol compound composition by high performance liquid chromatography, described method comprises the employing high performance liquid chromatography, with the potpourri of the water of the pH 3.0 of certain gradient ratio and organic phase as moving phase, 226nm is for detecting wavelength, at 30 ℃ column temperature, detect the related substance of the atenolol in nitrendipine and the atenolol compound composition with linear gradient elution method; With with the water of pH 3.0 and organic phase as moving phase, 235nm at 30 ℃ column temperature, detects the related substance of the nitrendipine in nitrendipine and the atenolol compound composition for detecting wavelength.
In a preferred embodiment, being used for gradient elution is the methyl alcohol of certain gradient ratio and the potpourri of pH3.0 phosphate buffer with the moving phase of the atenolol related substance that detects nitrendipine and atenolol compound composition.
In a further preferred embodiment, the gradient ratio that is used for the potpourri of the methyl alcohol of gradient elution and pH 3.0 phosphate buffers is: in the time of 0 minute, the volume ratio of methyl alcohol and phosphate buffer is 39: 61, in the time of 51 minutes, the volume ratio of methyl alcohol and phosphate buffer is 80: 20, in the time of 71 minutes, the volume ratio of methyl alcohol and phosphate buffer is 39: 61, finishes until wash-out.
In a preferred embodiment, the moving phase that is used for detecting the nitrendipine related substance of nitrendipine and atenolol compound composition is the potpourri of methyl alcohol and pH 3.0 phosphate buffers.
In a further preferred embodiment, the moving phase that is used for detecting the nitrendipine related substance of nitrendipine and atenolol compound composition is that volume ratio is 59: 41 the methyl alcohol and the potpourri of pH 3.0 phosphate buffers.
In another preferred embodiment, the pH3.0 phosphate buffer is prepared with potassium dihydrogen phosphate, perfluorooctane sulfonate, phosphoric acid and water.
In a further preferred embodiment, the pH3.0 phosphate buffer is by 6.8g potassium dihydrogen phosphate and 3.09g perfluorooctane sulfonate are dissolved in water, and is diluted to 1000ml, makes with phosphorus acid for adjusting pH value to 3.0.
In another preferred embodiment, the compound of being measured is that the weight ratio of wherein nitrendipine and atenolol is 2: 1 a compound.In a preferred embodiment, the compound of being measured is a composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
Summary of the invention
The invention provides the method that detects the related substance of nitrendipine and atenolol compound composition by high performance liquid chromatography, described method comprises the employing high performance liquid chromatography, with the potpourri of the water of the pH 3.0 of certain gradient ratio and organic phase as moving phase, 226nm is for detecting wavelength, column temperature 30 is with the related substance of the atenolol in linear gradient elution method detection nitrendipine and the atenolol compound composition; With with the water of pH 3.0 and organic phase as moving phase, 235nm at 30 ℃ column temperature, detects the related substance of the nitrendipine in nitrendipine and the atenolol compound composition for detecting wavelength.
In a specific embodiment, the inventive method may further comprise the steps:
The lucifuge operation, (two appendix VD of Chinese Pharmacopoeia version in 2005) measure according to high performance liquid chromatography;
1. atenolol
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with methyl alcohol is mobile phase A, pH 3.0 phosphate buffers (are got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, make with phosphorus acid for adjusting pH value to 3.0) be Mobile phase B, carry out wash-out according to following gradient: at the 0th minute, the volume ratio of mobile phase A and Mobile phase B was 39: 61; At 51 minutes, the volume ratio of mobile phase A and Mobile phase B was 80: 20; At 71 minutes, the volume ratio of mobile phase A and Mobile phase B was 39: 61, finishes until wash-out; Flow velocity is 1.0ml/ minute, and the detection wavelength is 226nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation that atenolol is adjacent impurity peaks should meet the requirements;
Measure: the fine powder of getting compound is an amount of, makes the solution that every 1ml contains the 0.4mg atenolol with methyl alcohol-pH 3.0 phosphate buffers (volume ratio 39: 61) dissolving and dilution, as need testing solution; Make the solution that every 1ml contains 4 μ g atenolols, solution in contrast with above-mentioned solvent dilution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height of major component chromatographic peak be about 20% of full scale; Precision is measured each 20 μ l of need testing solution and contrast solution again, injects liquid chromatograph respectively, record chromatogram to 50 minute; In the need testing solution chromatogram if any impurity peaks (desolventizing outside the peak), single impurity must not be greater than 1/2 (0.5%) of atenolol main peak area in the contrast solution, measure each impurity peak area and, must not be greater than the main peak area (1.0%) of atenolol in the contrast solution;
2. nitrendipine
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with volume ratio is that methyl alcohol-phosphate buffer of 59: 41 (is got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, and make with phosphorus acid for adjusting pH value to 3.0) be moving phase; Flow velocity is 1.0ml/ minute, and the detection wavelength is 235nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation of nitrendipine and nitrendipine impurity A should meet the requirements;
Measure: the fine powder of getting compound is an amount of, makes the solution that every 1ml contains the 0.2mg nitrendipine with described moving phase dissolving and dilution, as need testing solution; It is an amount of to get nitrendipine impurity A reference substance, make the solution that every 1ml contains 0.2mg nitrendipine impurity A with above-mentioned moving phase dilution, precision measures this solution of 1ml and the 1ml need testing solution places same 100ml measuring bottle, adds moving phase and is diluted to scale, shake up, in contrast solution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height at nitrendipine peak be about 20% of full scale; Precision is measured above-mentioned need testing solution and each 20 μ l of contrast solution again, injects liquid chromatograph respectively, and the record chromatogram is to 2.5 times of nitrendipine peak retention time; In the need testing solution chromatogram if any impurity peaks, except that disregarding less than 0.33 chromatographic peak with the relative retention time at nitrendipine peak, the peak area of single impurity must not be greater than the peak area (1.0%) of nitrendipine in the contrast solution, measure each impurity peak area sum, must not be greater than 3 times (3.0%) of nitrendipine peak area in the contrast solution.
Provide embodiment to further specify the present invention below, embodiment just illustrates the present invention, rather than limitation of the present invention.
Embodiment
Nitrendipine and atenolol compound tablet that use derives from Jiangsu Ji Beier Medicine Co.,Ltd carry out determination of related substances.Described tablet is respectively 20041012, and (every contains nitrendipine 4.9mg, contain atenolol 10.0mg, sheet heavily is 0.0854g), 20041013 (every contains nitrendipine 5.0mg, contains atenolol 10.0mg, and sheet heavily is 0.0849g), 20041014 (every contains nitrendipine 5.0mg, contain atenolol 10.0mg, sheet heavily is 0.0850g), 060801 (every contains nitrendipine 5.1mg, contain atenolol 9.7mg, sheet heavily is 0.0863g), 060802 (every contains nitrendipine 5.1mg, contains atenolol 9.8mg, sheet heavily is 0.0860g), 060803 (every contains nitrendipine 5.1mg, contains atenolol 9.8mg, and sheet heavily is 0.0866g).
The lucifuge operation, (two appendix VD of Chinese Pharmacopoeia version in 2005) measure according to high performance liquid chromatography;
1. atenolol
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with methyl alcohol is mobile phase A, pH 3.0 phosphate buffers (are got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, make with phosphorus acid for adjusting pH value to 3.0) be Mobile phase B, carry out gradient elution according to following table: flow velocity is 1.0ml/ minute, and the detection wavelength is 226nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation that atenolol is adjacent impurity peaks should meet the requirements;
| Time (minute) | Mobile phase A (volume %) | Mobile phase B (volume %) |
| ??0 | ??39 | ??61 |
| ??50 | ??39 | ??61 |
| ??51 | ??80 | ??20 |
| ??70 | ??80 | ??20 |
| ??71 | ??39 | ??61 |
| ??95 | ??39 | ??61 |
Determination method: the fine powder of getting composite tablet is an amount of, makes the solution that every 1ml contains the 0.4mg atenolol with methyl alcohol-pH 3.0 phosphate buffers (volume ratio 39: 61) dissolving and dilution, as need testing solution; Make the solution that every 1ml contains 4 μ g atenolols, solution in contrast with above-mentioned solvent dilution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height of major component chromatographic peak be about 20% of full scale; Precision is measured each 20 μ l of need testing solution and contrast solution again, injects liquid chromatograph respectively, record chromatogram to 50 minute; In the need testing solution chromatogram if any impurity peaks (desolventizing outside the peak), single impurity must not be greater than 1/2 (0.5%) of atenolol main peak area in the contrast solution, measure each impurity peak area and, must not be greater than the main peak area (1.0%) of atenolol in the contrast solution;
2. nitrendipine
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with volume ratio is that methyl alcohol-phosphate buffer of 59: 41 (is got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, and make with phosphorus acid for adjusting pH value to 3.0) be moving phase; Flow velocity is 1.0ml/ minute, and the detection wavelength is 235nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation that nitrendipine is adjacent impurity peaks should meet the requirements;
Determination method: the fine powder of getting composite tablet is an amount of, makes the solution that every 1ml contains the 0.2mg nitrendipine with described moving phase dissolving and dilution, as need testing solution; It is an amount of that precision is measured nitrendipine impurity A reference substance, make the solution that every 1ml contains 0.2mg nitrendipine impurity A with above-mentioned moving phase dilution, precision measures this solution of 1ml and the 1ml need testing solution places same 100ml measuring bottle, adds moving phase and is diluted to scale, shake up, in contrast solution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height at nitrendipine peak be about 20% of full scale; Precision is measured above-mentioned need testing solution and each 20 μ l of contrast solution again, injects liquid chromatograph respectively, and the record chromatogram is to 2.5 times of nitrendipine peak retention time; In the need testing solution chromatogram if any impurity peaks, except that disregarding less than 0.33 chromatographic peak with the relative retention time at nitrendipine peak, the peak area of single impurity must not be greater than the peak area (1.0%) of nitrendipine in the contrast solution, measure each impurity peak area sum, must not be greater than 3 times (3.0%) of nitrendipine peak area in the contrast solution.
Measurement result sees the following form:
Table 1: atenolol related substance testing result in nitrendipine and the atenolol compound tablet
Table 2: nitrendipine related substance testing result in nitrendipine and the atenolol compound tablet
The above results shows that the inventive method is feasible.
Atenolol: in the need testing solution chromatogram if any impurity peaks (desolventizing outside the peak), the peak area of single impurity must not greater than 1/2 (0.5%) of atenolol main peak area in the contrast solution measure impurity peak area and, must not be greater than atenolol main peak area (1.0%) in the contrast solution.
Nitrendipine: in the need testing solution chromatogram if any impurity peaks, except that disregarding less than 0.33 chromatographic peak with the relative retention time at nitrendipine peak, the peak area of single impurity must not be greater than the peak area (1.0%) of nitrendipine in the contrast solution, measure each impurity peak area sum, must not be greater than 3 times (3.0%) of nitrendipine peak area in the contrast solution.
Claims (10)
1. one kind is detected the method for the related substance of nitrendipine and atenolol compound composition by high performance liquid chromatography, and described method comprises
Adopt high performance liquid chromatography, with the potpourri of the water of the pH 3.0 of certain gradient ratio and organic phase as moving phase, 226nm at 30 ℃ column temperature, detects the related substance of the atenolol in nitrendipine and the atenolol compound composition for detecting wavelength with linear gradient elution method; With
As moving phase, 235nm at 30 ℃ column temperature, detects the related substance of the nitrendipine in nitrendipine and the atenolol compound composition for detecting wavelength with the water of pH 3.0 and organic phase.
2. method according to claim 1, wherein being used for gradient elution is the methyl alcohol of certain gradient ratio and the potpourri of pH 3.0 phosphate buffers with the moving phase of the atenolol related substance that detects nitrendipine and atenolol compound composition.
3. method according to claim 2, the gradient ratio that wherein is used for the potpourri of the methyl alcohol of gradient elution and pH 3.0 phosphate buffers is: in the time of 0 minute, the volume ratio of methyl alcohol and phosphate buffer is 39: 61, in the time of 51 minutes, the volume ratio of methyl alcohol and phosphate buffer is 80: 20, in the time of 71 minutes, the volume ratio of methyl alcohol and phosphate buffer is 39: 61, finishes until wash-out.
4. according to claim 1,2 or 3 described methods, the moving phase that wherein is used for detecting the nitrendipine related substance of nitrendipine and atenolol compound composition is the potpourri of methyl alcohol and pH 3.0 phosphate buffers.
5. method according to claim 4, the moving phase that wherein is used for detecting the nitrendipine related substance of nitrendipine and atenolol compound composition is that volume ratio is 59: 41 the methyl alcohol and the potpourri of pH3.0 phosphate buffer.
6. according to claim 2,3,4 or 5 described methods, wherein the pH3.0 phosphate buffer is prepared with potassium dihydrogen phosphate, perfluorooctane sulfonate, phosphoric acid and water.
7. method according to claim 6, wherein the pH3.0 phosphate buffer is by 6.8g potassium dihydrogen phosphate and 3.09g perfluorooctane sulfonate are dissolved in water, and is diluted to 1000ml, makes with phosphorus acid for adjusting pH value to 3.0.
8. method according to claim 7, wherein, the compound of being measured is that the weight ratio of wherein nitrendipine and atenolol is 2: 1 a compound.
9. method according to claim 5, wherein, the compound of being measured is a composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
10. method according to claim 1 wherein, said method comprising the steps of:
The lucifuge operation is measured according to the high performance liquid chromatography in the Chinese Pharmacopoeia;
(1) atenolol
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with methyl alcohol is mobile phase A, pH 3.0 phosphate buffers (are got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, make with phosphorus acid for adjusting pH value to 3.0) be Mobile phase B, carry out wash-out according to following gradient: at the 0th minute, the volume ratio of mobile phase A and Mobile phase B was 39: 61; At 51 minutes, the volume ratio of mobile phase A and Mobile phase B was 80: 20; At 71 minutes, the volume ratio of mobile phase A and Mobile phase B was 39: 61, finishes until wash-out; Flow velocity is 1.0ml/ minute, and the detection wavelength is 226nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation that atenolol is adjacent impurity peaks should meet the requirements;
Measure: the fine powder of getting compound is an amount of, makes the solution that every 1ml contains the 0.4mg atenolol with methyl alcohol-pH 3.0 phosphate buffers (volume ratio 39: 61) dissolving and dilution, as need testing solution; Make the solution that every 1ml contains 4 μ g, solution in contrast with above-mentioned solvent dilution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height of major component chromatographic peak be about 20% of full scale; Precision is measured each 20 μ l of need testing solution and contrast solution again, injects liquid chromatograph respectively, record chromatogram to 50 minute; In the need testing solution chromatogram if any impurity peaks (desolventizing outside the peak), single impurity must not be greater than 1/2 (0.5%) of atenolol main peak area in the contrast solution, measure each impurity peak area and, must not be greater than atenolol main peak area (1.0%) in the contrast solution;
(2) nitrendipine
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filling agent, with volume ratio is that methyl alcohol-phosphate buffer of 59: 41 (is got the 6.8g potassium dihydrogen phosphate and the 3.09g perfluorooctane sulfonate is dissolved in water, and be diluted to 1000ml, and make with phosphorus acid for adjusting pH value to 3.0) be moving phase; Flow velocity is 1.0ml/ minute, and the detection wavelength is 235nm, and column temperature is 30 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 2000, and the degree of separation of nitrendipine and nitrendipine impurity A should meet the requirements;
Measure: the fine powder of getting compound is an amount of, makes the solution that every 1ml contains 0.2mg with described moving phase dissolving and dilution, as need testing solution; It is an amount of that precision is measured nitrendipine impurity A reference substance, make the solution that every 1ml contains 0.2mg nitrendipine impurity A with above-mentioned moving phase dilution, precision measures this solution of 1ml and the 1ml need testing solution places same 100ml measuring bottle, adds moving phase and is diluted to scale, shake up, in contrast solution; Get contrast solution 20 μ l and inject liquid chromatograph, regulate detection sensitivity, make the peak height at nitrendipine peak be about 20% of full scale; Precision is measured each 20 μ l of above-mentioned need testing solution and contrast solution and is injected liquid chromatograph respectively again, and the record chromatogram is to 2.5 times of nitrendipine peak retention time; In the need testing solution chromatogram if any impurity peaks, except that disregarding less than 0.33 chromatographic peak with the relative retention time at nitrendipine peak, the peak area of single impurity must not be greater than the peak area (1.0%) of nitrendipine in the contrast solution, measure each impurity peak area sum, must not be greater than 3 times (3.0%) of nitrendipine peak area in the contrast solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810236311A CN101738438B (en) | 2008-11-26 | 2008-11-26 | Detection method of related substances of nitrendipine and atenolol compound composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810236311A CN101738438B (en) | 2008-11-26 | 2008-11-26 | Detection method of related substances of nitrendipine and atenolol compound composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101738438A true CN101738438A (en) | 2010-06-16 |
| CN101738438B CN101738438B (en) | 2012-10-10 |
Family
ID=42462182
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810236311A Active CN101738438B (en) | 2008-11-26 | 2008-11-26 | Detection method of related substances of nitrendipine and atenolol compound composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101738438B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239723A (en) * | 2013-04-26 | 2013-08-14 | 江苏吉贝尔药业有限公司 | Compound antihypertensive agent |
-
2008
- 2008-11-26 CN CN200810236311A patent/CN101738438B/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239723A (en) * | 2013-04-26 | 2013-08-14 | 江苏吉贝尔药业有限公司 | Compound antihypertensive agent |
| CN103239723B (en) * | 2013-04-26 | 2014-03-19 | 江苏吉贝尔药业有限公司 | Compound antihypertensive agent |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101738438B (en) | 2012-10-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Patil et al. | Simultaneous determination of lamotrigine, phenobarbitone, carbamazepine and phenytoin in human serum by high-performance liquid chromatography | |
| Nakashima et al. | Determination of donepezil hydrochloride in human and rat plasma, blood and brain microdialysates by HPLC with a short C30 column | |
| Takahashi et al. | Determination of plasma tenofovir concentrations using a conventional LC-MS method | |
| Wu et al. | Pharmacokinetics of (±)‐,(+)‐, and (−)‐gossypol in humans and dogs | |
| CN102138892B (en) | Choline alfoscerate injection preparation as well as preparation method and detection method thereof | |
| Obando et al. | Simultaneous determination of hydrochlorothiazide and losartan potassium in tablets by high-performance low-pressure chromatography using a multi-syringe burette coupled to a monolithic column | |
| Eldin et al. | The development of a new validated HPLC and spectrophotometric methods for the simultaneous determination of daclatasvir and sofosbuvir: antiviral drugs | |
| Phalguna et al. | Analytical method development and validation for the estimation of sacubitril and valsartan in combined pharmaceutical dosage forms by RP-HPLC | |
| VenkataRao et al. | Determination of sorafenib in bulk and tablet formulation by a new validated reverse phase high performance liquid chromatography | |
| Peake et al. | Measurement of neosaxitoxin in human plasma using liquid–chromatography tandem mass spectrometry: Proof of concept for a pharmacokinetic application | |
| CN101738438B (en) | Detection method of related substances of nitrendipine and atenolol compound composition | |
| Steffansen et al. | Stability, metabolism and transport of d-Asp (OBzl)–Ala—a model prodrug with affinity for the oligopeptide transporter | |
| Tozo et al. | Determination of lomefloxacin in tablet preparations by liquid chromatography | |
| Herring et al. | Simple method for determination of terbutaline plasma concentration by high-performance liquid chromatography | |
| Unsalan et al. | Therapeutic monitoring of isoniazid, pyrazinamide and rifampicin in tuberculosis patients using LC | |
| Valizadeh et al. | Single dose bioequivalence study of α-methyldopa tablet formulations using a modified HPLC method | |
| Shin et al. | Sensitive assay for verapamil in plasma using gas-liquid chromatography with nitrogen-phosphorus detection | |
| Fanse | RPHPLC method for Simultaneous Estimation of Lansoprazole and aspirin in Bulk and Laboratory Mixture | |
| CN112924594B (en) | Method for measuring content of levo-muscone | |
| CN104237399A (en) | Method for detecting ambrisenta crud materials and content of ambrisenta active ingredients in preparations | |
| CN100401058C (en) | Joint measurement method of nitrendipine and atenolol | |
| CN101738455A (en) | Dissolution detection method of nitrendipine and atenolol compound composition | |
| CN102847164B (en) | Application of chrysalis oil in improving small molecule drug bioavailability | |
| CN103163232A (en) | Method of content determination and impurity determination of lenalidomide and preparations of lenalidomide | |
| Kumar et al. | A validated analytical HPLC method for the quantification of lincomycin hydrochloride in bulk and solid dosage form |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C56 | Change in the name or address of the patentee |
Owner name: JIANGSU JIBEIER PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGSU JIBEIER PHARMA CO., LTD. |
|
| CP01 | Change in the name or title of a patent holder |
Address after: 212009 hi tech Development Zone, Jiangsu, Zhenjiang Patentee after: Jiangsu Jibeier Pharmaceutical Co., Ltd. Address before: 212009 hi tech Development Zone, Jiangsu, Zhenjiang Patentee before: Jiangsu Jibeier Pharm Co., Ltd. |