CN101852782B - Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations - Google Patents
Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations Download PDFInfo
- Publication number
- CN101852782B CN101852782B CN2009101320082A CN200910132008A CN101852782B CN 101852782 B CN101852782 B CN 101852782B CN 2009101320082 A CN2009101320082 A CN 2009101320082A CN 200910132008 A CN200910132008 A CN 200910132008A CN 101852782 B CN101852782 B CN 101852782B
- Authority
- CN
- China
- Prior art keywords
- faropenem
- content
- preparation
- mobile phase
- solution
- 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.)
- Active
Links
Images
Abstract
The invention particularly relates to a method for measuring the content of faropenem polymers in faropenem sodium raw materials and preparations by high-efficiency liquid chromatography, which belongs to the field of medicine analysis. The measuring method of the invention is gel chromatography. The high-efficiency liquid chromatogram is used for detection, and the chromatogram conditions are as follows: (1) the gel permeation chromatography has the exclusion molecular weight between 600 and 800 Daltons; (2) the mobile phases as two mobile phases, wherein the mobile phase A is a water phase solution with the pH value between 5.0 and 8.5 and the concentration between 0.01 and 0.2 mol/L, and the mobile phase B is water or a sodium dodecyl sulfate water solution or a glycin solution between 0.005 and 0.02 percent; (3) the column temperature is the room temperature; (4) the flowing rate is between 0.5 and 1.0 ml/min; and (5) the detection wavelength is between 210 and 300 nm. The method of the invention has the advantages of strong specificity, good repetitiveness and high automation degree, and the polymers in the faropenem sodium raw materials and the preparations can be accurately qualified.
Description
Technical field
The invention belongs to the Pharmaceutical Analysis field, be specifically related to the method for faropenem polymer content in high effective liquid chromatography for measuring faropenem sodium raw materials and the preparation thereof.
Background technology
Faropenem is an atypia beta-lactam antibiotic, belongs to the derivant of penems.Carbapenems and penems two big compounds have attracted the great interest of people, and penems more has unique advantage, and existing five malicious vinyl derivatives of green grass or young crops are among exploitation, and faropenem is one of them.Except that more weak to the inhibition Pseudomonas aeruginosa, its has a broad antifungal spectrum, effective especially to anaerobion surpasses carbapenem antibiotic.It demonstrates broad-spectrum antibacterial activity to aerobic and gram positive bacteria, gram-negative bacteria anaerobism, and particularly the activity to anaerobions such as gram positive bacteria such as the staphylococcus of resistance, enterococcus and bacteroids all is better than existing Perorally administrable antimicrobial medicine.Faropenem and PBP have good affinity and good beta-lactam enzyme stability, and less generation resistance is mainly used in infection in respiratory system, urinary system infection contamination, genital system infection and infection of biliary tract etc. due to the sensitive bacterial.
Along with the microbiotic widespread use, the bad reaction that microbiotic causes more and more causes people's attention.The type that beta-lactam antibiotic causes is clinical modal bad reaction, harm to the patient reaches big, studies show that just haptens of beta-lactam antibiotic itself, and all kinds of high molecular polymerization impurity that wherein exist are only the real anaphylactogen that causes type, and it is extremely important controlling therefore that its polymkeric substance limits the quantity of.Faropenem sodium is the same with similar other drug, and they often cause the anaphylactic shock reaction clinically, and patient's safety in serious threat.Studies have shown that the anaphylactogen that causes the beta-lactam antibiotic type is relevant with the high molecular polymer content that wherein exists, so the mensuration of high molecular polymer in this type of medicine is more and more caused people's attention.
Gel chromatography technology is a kind of quick and simple separate analytical technique that early sixties grows up, because equipment is simple, easy to operate, does not need organic solvent, and polymer substance is had very high separating effect.Utilize the molecular sieve mechanism of gel chromatography, allow drug molecule freely enter gel particle inside, and allow macromolecule impurity by exclusion; Because have multiple secondary interaction between solute molecule and gel media, solute molecule can be adsorbed on the surface of gel media; In gel particle inside, gel particle has bigger specific surface area and less free space, so solute molecule is easier to be contacted with gel media, thereby solute molecule is adsorbed than the gel particle outside is easier in gel particle inside, be in the chromatographic process except that the molecular exclusion effect, gel to the suction-operated of medicine greater than suction-operated to macromolecule impurity.Principle can make the degree of separation between macromolecule impurity and drug molecule increase in view of the above.
The report that the polymer content mensuration of multiple beta-lactam antibiotic has been arranged at present, wherein sheet pharmacopeia in 2005 is to cefotaxime, Ceftriaxone Sodium, cefoperazone sodium, Cefotaxime Sodium, Cefradine, Cefazolin sodium, Cefuroxime Sodium, Benzylpenicillin sodium salt, benzylpenicillin potassium, ospeneff, 11 antibiotic polymer determination methods such as Amoxicillin are included, document is also arranged to Cefodizime Sodium, the assay method of Cefotaxime Sodium and ceftezole sodium polymer is studied, Yang Pengfei etc. in " with the polymkeric substance in 8 kinds of cephalosporin for injections of sephadex G-10 system thinking " to cefonicid for inj, injection cefathiamidine sodium, cefoxitin for inj, ceftiaoxline sodium for injection, the injection Cefozopran, cefodizime sodium for injection, polymkeric substance in 8 kinds of cephalosporin for injections such as cefotetan for inj sodium has carried out systematic study.Therefore the present also report of the concrete assay method of unmatchful faropenem polymkeric substance has important meaning for the method for setting up the faropenem polymer determination for the quality control of carrying out carbapenem antibiotic and safe medication.
Summary of the invention
The method that the purpose of this invention is to provide faropenem polymer content in a kind of determination method faropenem raw material and the preparation.We have set up a kind of high performance liquid chromatogram exclusion chromatography that the content of faropenem sodium polymer in faropenem sodium raw materials and the preparation is measured.The inventor makes the assay method degree of separation of faropenem polymkeric substance good by conditions such as aqueous solution kind, ionic strength, solution concentration, pH value of solution, flow velocity, column temperature, chromatographic column and wavelength are groped, and post is imitated high, good reproducibility.
The method of faropenem polymeric impurities content in determination method faropenem raw material provided by the invention and the preparation, this method is an exclusion chromatography, uses high performance liquid chromatograph to detect, chromatographic condition is:
1. gel chromatographic columns: the exclusion molecular weight is 600-800 dalton;
2. moving phase has two kinds: mobile phase A: concentration is the aqueous phase solution between the 0.01-0.2mol/L, and regulating the pH value with the pH regulator agent is 6.5-8.5; Mobile phase B: sodium dodecyl sulfate solution between water or the 0.005-0.02% or glycine solution;
3. column temperature: room temperature;
4. flow velocity: 0.5-1.0ml/min;
5. detect wavelength: 210-300nm.
The method of Faropenem sodium polymer content in wherein above-mentioned described determination method faropenem raw material and the preparation, described gel chromatographic columns is selected from sephadex G-10 gel chromatographic columns.
The method of faropenem polymer content in wherein above-mentioned described determination method faropenem raw material and the preparation, described sephadex G-10 gel chromatography, internal diameter is: 5～20mm; Length: 200～500mm; Granularity: 40～60um; Aperture: 50～70A; Post bed: 1.5～3.5mL/g.
The method of faropenem polymer content in wherein above-mentioned described determination method faropenem raw material and the preparation, the aqueous phase solution of described mobile phase A is NaH
2PO
4, NH
4CL, Na
2HPO
4, KH
2PO
4, K
2HPO
4, NH
4H
2PO
4, (NH
4)
2HPO
4One or more mixed aqueous solution, preferred NaH
2PO
4And Na
2HPO
4Mixed aqueous solution, NaH
2PO
4Concentration be 0.01-0.2mol/L, Na
2HPO
4Concentration be 0.01-0.2mol/L.
The method of faropenem polymer content in wherein above-mentioned described determination method faropenem raw material and the preparation, the pH regulator agent of described mobile phase A is selected from NaOH, phosphoric acid, ammoniacal liquor and HCL etc.
The standard that wavelength is chosen is relevant with the optical absorption property of material to be checked, to cephalosporin analog antibiotic, its maximum absorption wavelength is fixed, and passes through UV scanning, discovery method faropenem polymkeric substance 210～300nm place wavelength all has stronger uv absorption, all can be used as the detection wavelength.
The method of faropenem polymer content in wherein above-mentioned described determination method faropenem raw material and the preparation, wherein said method is calibration curve method or external standard method.
1) described typical curve comprises the steps:
1. make typical curve: get the known faropenem reference substance of content and be contrast, gradient dilution is a moving phase with the Mobile phase B, cross gel chromatographic columns, under the detection wavelength, detect, the record chromatogram, obtain parameters such as retention time, peak height, peak area, obtain typical curve;
2. calibration curve method is measured the faropenem polymer content: raw material to be measured or preparation water are mixed with certain density solution as solvent, with the mobile phase A is moving phase, cross the gel column chromatography post, under the detection wavelength, detect, the record chromatogram, obtain parameters such as peak height and peak area, and, calculate the content of faropenem polymkeric substance the correlation parameter substitution typical curve of faropenem polymkeric substance correspondence.
2) described external standard method comprises the steps:
1. the typical curve and the range of linearity: get the known faropenem reference substance of content and be contrast, gradient dilution is a moving phase with the Mobile phase B, cross gel chromatographic columns, under the detection wavelength, detect, the record chromatogram, obtain parameters such as peak height and peak area, obtain the typical curve and the range of linearity;
2. external standard method faropenem polymer content: in the range of linearity, select suitable concentration, preparation contrast solution and sample solution are measured under selected chromatographic condition, the record chromatogram, calculate with correlation parameter by external standard method, obtain the content of faropenem polymkeric substance.
The present invention possesses following beneficial effect and marked improvement:
1. the method for faropenem polymer content in determination method faropenem raw material of the present invention and the preparation, adopt the high performance liquid chromatogram exclusion chromatography that the faropenem sodium polymer is carried out quantitative measurement first, this method automaticity height, be beneficial to operation, for the amount of better controlling polymkeric substance in faropenem raw material and the preparation provides a kind of reliable method.
2. the method for faropenem polymer content in determination method faropenem raw material of the present invention and the preparation, the specificity height, degree of separation is good, the impurity of faropenem polymkeric substance in sizing technique faropenem raw material that the post effect is high, good reproducibility can be correct and the preparation thereof, guarantee the assurance product quality, improved the security of medication.
Description of drawings
Fig. 1 is the HPLC spectrogram of faropenem reference substance in Mobile phase B
Fig. 2 is the HPLC spectrogram of faropenem sodium raw materials in mobile phase A
Specific embodiment
Embodiment 1: faropenem polymer content in calibration curve method determination method faropenem raw material and the preparation thereof
One, chromatographic condition
Instrument: U.S. Agilent 1100 series of high efficiency liquid chromatographs;
Gel chromatographic columns: Sephadex G-10,15.0mm * 400mm;
Moving phase: mobile phase A: NaH
2PO
41.08g and Na
2HPO
44.38g to 1000ml water, use H
3PO
4Transfer pH to 7.0;
Mobile phase B: 0.01% lauryl sodium sulfate
Flow velocity: 1.0ml/min
Column temperature: room temperature;
Wavelength: 254nm
Two, experimental procedure:
1, make typical curve:
1. faropenem reference substance 62.5mg places the 50ml volumetric flask, and water is diluted to 0.05,0.10,0.15,0.20,0.25,0.30 and the solution of 0.4mg/ml with it, shakes up;
2. get each each 20ul of dilution point reference substance solution and pass through gel column successively, with the Mobile phase B is moving phase, under the 254nm wavelength, detect, the record chromatogram, the HPLC chromatogram is seen Fig. 1, obtains the reservation peak area, with concentration (C) peak area (A) is carried out linear regression, obtain typical curve and linear equation, calculate regression coefficient;
3. calculating regression equation is: C=58253A-19.734 R
2=0.9997
2, the content of determination method faropenem polymkeric substance
Get the faropenem sodium raw materials that is equivalent to faropenem 50mg or preparation place the 100ml volumetric flask, add purified water and be mixed with solution to be measured, cross gel chromatographic columns, under the 254nm wavelength, detect, the record chromatogram, the HPLC spectrogram is seen Fig. 2, obtains the polymkeric substance peak area, and, obtain the content value of polymkeric substance with the peak area substitution linear equation of faropenem sodium polymer.
Three, result
As shown in Figure 2, retention time is that 24.827 minutes absorption peak is the characteristic peak of faropenem polymkeric substance on the chromatogram, and directly with detected peak area value substitution regression equation, the content that can record the faropenem polymkeric substance is 0.24%.
Duplicate detection 5 times, the RSD value that the results are shown in Table the peak area of faropenem polymkeric substance is 0.06%, illustrates that this method has good reappearance.
Embodiment 2: faropenem polymer content in calibration curve method determination method faropenem raw material and the preparation thereof
One, chromatographic condition
With embodiment 1
Two, experimental procedure:
1, make typical curve:
1. faropenem reference substance 62.5mg places the 50ml volumetric flask, and water is diluted to 0.05,0.10,0.15,0.20,0.25,0.30 and the solution of 0.4mg/ml with it, shakes up;
2. getting each each 20ul of dilution point reference substance solution successively by gel column, is moving phase with the Mobile phase B, detects under the 254nm wavelength, the record chromatogram obtains the reservation peak area, with concentration (C) peak area (A) is carried out linear regression, obtain typical curve and linear equation, calculate regression coefficient;
3. calculating regression equation is: C=57203A+76.287 R
2=0.9999
3, the content of determination method faropenem polymkeric substance
1. the preparation of contrast solution and test solution: follow the example of faropenem reference substance 31.25mg extremely, add purified water and be mixed with reference substance solution; Get the faropenem sodium raw materials that is equivalent to faropenem 50mg or preparation place the 100ml volumetric flask, add purified water and be mixed with solution to be measured.
2. contrast solution is moving phase with the Mobile phase B, crosses gel chromatographic columns, detects under the 254nm wavelength, writes down chromatogram, obtains the peak area of reference substance; Test liquid is moving phase with the mobile phase A, crosses gel chromatographic columns, and the record chromatogram obtains the polymkeric substance peak area.
3. according to the content value of external standard method computing formula polymkeric substance.
Three, result
Calculate the content 0.24% of Luo Peinan polymkeric substance by external standard method.The RSD value is 0.05%.
Embodiment 3: faropenem polymer content in calibration curve method determination method faropenem raw material and the preparation thereof
One, chromatographic condition
Instrument: U.S. Agilent 1100 series of high efficiency liquid chromatographs;
Gel chromatographic columns: Sephadex G-10,15.0mm * 400mm;
Moving phase: mobile phase A: get NH
4In Cl 0.54g to the 1000ml water, transfer pH to 7.0 with NaOH
Mobile phase B: 0.01% lauryl sodium sulfate
Flow velocity: 1.0ml/min
Column temperature: room temperature;
Wavelength: 254nm
Two, experimental procedure is with embodiment 1
Three, result
Calculate the content 0.25% of Luo Peinan polymkeric substance by calibration curve method.The RSD value is 0.06%.
Embodiment 4: faropenem polymer content in external standard method faropenem sodium raw materials and the preparation thereof
One, chromatographic condition
Instrument: U.S. Agilent 1100 series of high efficiency liquid chromatographs;
Gel chromatographic columns: Sephadex G-10,15.0mm * 400mm;
Moving phase: mobile phase A: get NH
4H
2PO
41.15g to 1000ml water, transfer pH to 7.0 with NaOH
Mobile phase B: 0.01% lauryl sodium sulfate
Flow velocity: 1.0ml/min
Column temperature: room temperature;
Wavelength: 254nm
Two, experimental procedure is with embodiment 2
Three, result
Calculate the content 0.27% of Luo Peinan polymkeric substance by external standard method.The RSD value is 0.08%.
Claims (1)
1. the method for faropenem polymeric impurities content in determination method faropenem raw material and the preparation, it is characterized in that: this method is an exclusion chromatography, uses high performance liquid chromatograph to detect, chromatographic condition is:
1. gel chromatographic columns: the exclusion molecular weight is 600-800 dalton;
2. moving phase has two kinds: mobile phase A: NaH
2PO
41.08g and Na
2HPO
44.38g to 1000ml water, use H
3PO
4Transfer pH to 7.0; Or get NH
4In Cl 0.54g to the 1000ml water, transfer pH to 7.0 with NaOH; Or get NH
4H
2PO
41.15g to 1000ml water, transfer pH to 7.0 with NaOH;
Mobile phase B: sodium dodecyl sulfate solution between the 0.005-0.02% or glycine solution;
3. column temperature: room temperature;
4. flow velocity: 0.5-1.0ml/min;
5. detect wavelength: 210-300nm.
2, according to the method for Faropenem sodium polymer content in claims 1 described determination method faropenem raw material and the preparation, it is characterized in that described gel chromatographic columns is selected from sephadex G-10 gel chromatographic columns.
3, according to the method for faropenem polymer content in claims 2 described determination method faropenem raw materials and the preparation, it is characterized in that, described sephadex G-10 gel chromatographic columns, internal diameter is: 5 ~ 20mm; Length: 200 ~ 500mm; Granularity: 40 ~ 60um; Aperture: 50 ~ 70A; Post bed: 1.5 ~ 3.5mL/g.
4, according to the method for faropenem polymer content in arbitrary described determination method faropenem raw material of claims 1-3 and the preparation, it is characterized in that it is a calibration curve method, comprises the steps:
1. make typical curve: get the known faropenem reference substance of content and be contrast, gradient dilution is a moving phase with the Mobile phase B, cross gel chromatographic columns, under the detection wavelength, detect, the record chromatogram, obtain parameters such as retention time, peak height, peak area, obtain typical curve;
2. calibration curve method is measured the faropenem polymer content: raw material to be measured or preparation water are mixed with certain density solution as solvent, with the mobile phase A is moving phase, cross the gel column chromatography post, under the detection wavelength, detect, the record chromatogram, obtain parameters such as peak height and peak area, and, calculate the content of faropenem polymkeric substance the correlation parameter substitution typical curve of faropenem polymkeric substance correspondence.
5, according to the method for faropenem polymer content in arbitrary described determination method faropenem raw material of claims 1-3 and the preparation, it is characterized in that it is an external standard method, comprises the steps:
1. the typical curve and the range of linearity: get the known faropenem reference substance of content and be contrast, gradient dilution is a moving phase with the Mobile phase B, cross gel chromatographic columns, under the detection wavelength, detect, the record chromatogram, obtain parameters such as peak height and peak area, obtain the typical curve and the range of linearity;
2. external standard method faropenem polymer content: in the range of linearity, select suitable concentration, preparation contrast solution and sample solution are measured under selected chromatographic condition, the record chromatogram, calculate with correlation parameter by external standard method, obtain the content of faropenem polymkeric substance.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101320082A CN101852782B (en) | 2009-04-02 | 2009-04-02 | Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101320082A CN101852782B (en) | 2009-04-02 | 2009-04-02 | Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101852782A CN101852782A (en) | 2010-10-06 |
| CN101852782B true CN101852782B (en) | 2011-11-30 |
Family
ID=42804367
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009101320082A Active CN101852782B (en) | 2009-04-02 | 2009-04-02 | Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101852782B (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103063751A (en) * | 2011-10-20 | 2013-04-24 | 苏州赛分科技有限公司 | Detection method for determining polymer impurities in mezlocillin sodium |
| CN107561173B (en) * | 2017-07-18 | 2020-04-10 | 江苏正大清江制药有限公司 | Method for measuring high-molecular polymer in Ropeinan sodium powder injection |
| CN107576735B (en) * | 2017-07-18 | 2020-07-10 | 江苏正大清江制药有限公司 | Method for measuring high-molecular polymer in ropinan sodium |
| CN112763584A (en) * | 2019-11-05 | 2021-05-07 | 江苏先声药业有限公司 | Method for detecting polymer in amoxicillin granules |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1437019A (en) * | 2003-03-04 | 2003-08-20 | 南京振中生物工程有限公司 | Lentinan molecular weight and molecular weight distribution measuring method |
| CN1566941A (en) * | 2003-07-08 | 2005-01-19 | 北京三诺佳邑生物技术有限责任公司 | Method for measuring nerve growth factor content in preparation |
| CN101191787A (en) * | 2006-11-21 | 2008-06-04 | 上海医药工业研究院 | High performance liquid chromatography method for measuring doripenem content |
| CN101348494A (en) * | 2008-09-02 | 2009-01-21 | 海南数尔药物研究有限公司 | High-purity cefmenoxime hydrochloride and preparation thereof |
-
2009
- 2009-04-02 CN CN2009101320082A patent/CN101852782B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1437019A (en) * | 2003-03-04 | 2003-08-20 | 南京振中生物工程有限公司 | Lentinan molecular weight and molecular weight distribution measuring method |
| CN1566941A (en) * | 2003-07-08 | 2005-01-19 | 北京三诺佳邑生物技术有限责任公司 | Method for measuring nerve growth factor content in preparation |
| CN101191787A (en) * | 2006-11-21 | 2008-06-04 | 上海医药工业研究院 | High performance liquid chromatography method for measuring doripenem content |
| CN101348494A (en) * | 2008-09-02 | 2009-01-21 | 海南数尔药物研究有限公司 | High-purity cefmenoxime hydrochloride and preparation thereof |
Non-Patent Citations (3)
| Title |
|---|
| 宋会娟.葡聚糖凝胶色谱法测定头孢替坦二钠中聚合物含量的方法研究.《现代食品与药品杂志》.2007,第17卷(第5期),52-54. * |
| 杨鹏飞.以葡聚糖凝胶G_10系统考察8种注射用头孢菌素中的聚合物.《江苏药学与临床研究》.2006,第14卷(第5期),287-290. * |
| 高丹玲.葡聚糖凝胶柱层析法分离测定头孢尼西钠中的聚合物.《中国药事》.2006,第20卷(第8期),493-495. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101852782A (en) | 2010-10-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101852782B (en) | Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations | |
| Sun et al. | Simultaneous determination of the combined drugs of ceftriaxone sodium, metronidazole, and levofloxacin in human urine by high‐performance liquid chromatography | |
| Talebpour et al. | Determination of cefixime by a validated stability-indicating HPLC method and identification of its related substances by LC-MS/MS studies | |
| CN103487518B (en) | Impurity detection method and content determination method for clindamycin hydrochloride for injection | |
| Goldwirt et al. | A new UPLC-MS/MS method for the determination of irinotecan and 7-ethyl-10-hydroxycamptothecin (SN-38) in mice: application to plasma and brain pharmacokinetics | |
| CN110146621A (en) | The content assaying method of polymer in cephalosporin analog antibiotic drug | |
| CN105560194A (en) | High-purity ceftazidime powder injection and preparation method thereof | |
| CN104458984A (en) | Method for determining polymer in cephalosporins drug | |
| CN104215697A (en) | Method for detecting related substances in piperacillin sodium and sulbactum sodium for injection | |
| CN105037276A (en) | Cefoperazone sodium hydrolyzate and preparation method and use thereof | |
| CN105085570A (en) | Tedizolid phosphate compound and preparation method thereof | |
| RU2416792C1 (en) | Method of ciprofloxacin evaluation in drug preparations | |
| CN106093263A (en) | A kind of ceftriaxone sodium for injection method of quality control | |
| Barot et al. | Development and validation of LC method for the determination of ampicillin and dicloxacillin in pharmaceutical formulation using an experimental design | |
| Abd El Aziz Shama et al. | A simultaneous, validated RP-HPLC method for determination of eight cephalosporins in pharmaceutical formulations | |
| Tozo et al. | Determination of lomefloxacin in tablet preparations by liquid chromatography | |
| CN111239265B (en) | Liquid chromatography method for determining clavulanic acid related substances in amoxicillin and potassium clavulanate pharmaceutical composition | |
| CN102759586B (en) | Method for measuring content of sulfhydryl compound in composition by high performance liquid chromatography | |
| CN102207492B (en) | Quantitative analysis method for biapenem dimer in biapenem | |
| CN105004803A (en) | Liquid chromatographic method for separating and determining multiple impurities in tolvaptan | |
| CN102507758B (en) | Detection method of cis-trans isomer in cis-propenyl phosphonic acid and related impurity thereof | |
| Shanmugasundaram et al. | Simultaneous estimation of amoxicillin and flucloxacillin in its combined capsule dosage form by HPLC | |
| Mujtaba et al. | Validated HPLC method for the pharmacokinetic study of oral extended-release cefpodoxime proxetil chitosan–alginate beads in rabbits | |
| CN113219080A (en) | HPLC (high Performance liquid chromatography) detection method for high-molecular impurities in cefepime and preparation thereof | |
| CN102841155A (en) | Method for detecting related substances in fosfomycin sodium by high-performance liquid chromatography |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Shandong Xinshidai Pharmaceutical Industry Co., Ltd. Assignor: Lunan Pharmaceutical Group Co., Ltd. Contract record no.: 2010370000509 Denomination of invention: Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations License type: Exclusive License Open date: 20101006 Record date: 20100908 |
|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EC01 | Cancellation of recordation of patent licensing contract |
Assignee: Shandong Xinshidai Pharmaceutical Industry Co., Ltd. Assignor: Lunan Pharmaceutical Group Co., Ltd. Contract record no.: 2010370000509 Date of cancellation: 20121226 |
|
| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model |