CN109613128A - The measuring method of drug content in a kind of Famotidine Capsule - Google Patents
The measuring method of drug content in a kind of Famotidine Capsule Download PDFInfo
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- CN109613128A CN109613128A CN201811353146.9A CN201811353146A CN109613128A CN 109613128 A CN109613128 A CN 109613128A CN 201811353146 A CN201811353146 A CN 201811353146A CN 109613128 A CN109613128 A CN 109613128A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
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Abstract
The present invention provides a kind of measuring methods of drug content in Famotidine Capsule, using the mixed solvent of potassium dihydrogen phosphate and methanol as mobile phase, using methanol as diluent, are detected using high performance liquid chromatography (HPLC), Detection wavelength 270nm.The mixed solvent of the potassium dihydrogen phosphate and methanol by mass percent concentration be 0.125% potassium dihydrogen phosphate aqueous solution and methanol by volume (60-80): (35-45) is configured.Measuring method of the present invention, it can precise determination famotidine solid pharmaceutical preparation content, it solves and the problems such as detection efficiency is low, detection error is big and accuracy is not high exists in the prior art, while important references can be provided to improve detection level cloud test accuracy in famotidine solid pharmaceutical preparation.
Description
Technical field
The present invention relates to a kind of surveys of drug content in Pharmaceutical Analysis detection technique field more particularly to Famotidine Capsule
Determine method.
Background technique
Famotidine (Famotidine, FAM) is the 3rd generation H2 receptor antagonist occurred after Cimetidine and ranitidine
Medicine, action intensity is 30-100 times bigger than Cimetidine, 6-10 times bigger than ranitidine, for treating taste-blindness rate
With other acute gastrointestinal diseases, have to stomach lining H2 receptor affinity is high, effect is good, adverse reaction is few, patient tolerability
The features such as well and not influencing other medicines metabolism, clinical application is more and more extensive.But famotidine absorbs not exclusively in gastrointestinal tract,
Oral administration biaavailability is only 40%-50%.Therefore, widespread practice is that famotidine is made to gastric retention solid pharmaceutical preparation, is prolonged
Its long residence time in stomach, to achieve the purpose that the curative effect for increasing drug.
Famotidine solid pharmaceutical preparation uniformity of dosage units is using ultraviolet-visible in 2015 editions Chinese Pharmacopoeias of present
Light photometry calculates uniformity of dosage units with absorption coefficient, and this analysis method human intervention factor is more, testing staff if you need to
Multiple batches of continuous detection, may cause inefficiency, be easy to appear the unfavorable factors such as mistake.
In addition, publication CN10652578A discloses sulfur-bearing bisfentidine class drug in a kind of measurement drug
The method of content, main technical schemes are to utilize fluorescence method indirect determination sulfur-bearing bisfentidine class reproducibility drug, benefit
Redox reaction occurs with oxidant N- bromo-succinimide and sulfur-bearing bisfentidine class reproducibility drug, by sulfur-bearing
Sulphur in bisfentidine class reproducibility drug is oxidized to sulfoxide, and selectivity is stronger, reacts more sensitive.And it discloses specially
Sharp CN10325719A discloses a kind of measurement brufen/famotidine compound preparation content method, and method is washed with gradient
It is de-, it is cumbersome by the concentration proportioning for constantly changing mobile phase to a certain degree in the same analytical cycle, it easily causes
Baseline drift, analytical cycle is too long (could terminate within about 35 minutes), equally exists that detection efficiency is low, detection error is big, accuracy
The defects of not high.
Summary of the invention
Required the technical issues of solving of the invention is that there are detection error, accuracy be not high for existing detection technique
Defect provides a kind of measuring method of drug content in Famotidine Capsule.
To achieve the above object, the invention adopts the following technical scheme:
The present invention provides a kind of measuring method of drug content in Famotidine Capsule, with the mixed of potassium dihydrogen phosphate and methanol
Bonding solvent is mobile phase, using methanol as diluent, is detected using high performance liquid chromatography (HPLC), Detection wavelength is
270nm。
Further, in the Famotidine Capsule in the measuring method of drug content, the potassium dihydrogen phosphate and
The potassium dihydrogen phosphate aqueous solution and methanol (60- by volume that the mixed solvent of methanol is 0.125% by mass percent concentration
80): (35-45) is configured.
Further, in the Famotidine Capsule in the measuring method of drug content, described 0.125% phosphoric acid
Dihydro aqueous solutions of potassium and methanol are 70:30 by volume.
Further, in the Famotidine Capsule in the measuring method of drug content, the detector bar of the HPLC
Part is as follows:
Chromatographic column: 250 × 4.6mm of C18 column；
Mobile phase: the mixed solvent of 0.125% potassium dihydrogen phosphate and methanol；
Flow velocity: 1.2-1.8ml/min；
Detection wavelength: 270nm；
Sample volume: 15-25 μ l；
Column temperature: 26-34 DEG C；
System suitability: number of theoretical plate is not less than 1000.
Further, in the Famotidine Capsule in the measuring method of drug content, the detection side of the HPLC
Method is as follows:
(1) preparation of reference substance solution: taking famotidine reference substance about 10mg, accurately weighed, adds methanol to be configured to 1ml and contains
The solution of famotidine 10ug, both；
(2) preparation of test solution: precision weighs famotidine solid pharmaceutical preparation fine powder 0.1g, weighed, sets 100ml measuring bottle
In, add methanol dilution to scale, shakes up；Precision measures 1ml, sets in 100ml measuring bottle, adds methanol solution to scale, shake up, both
?；
(3) measuring method: it is accurate respectively to measure contrast solution and each 20ul of test solution, high performance liquid chromatograph is injected,
Measure famotidine content.
It is further preferred that in the Famotidine Capsule in the measuring method of drug content, the famotidine
Methanol solution preparation method are as follows: precision weighs Famotidine Capsule about 165mg, 171mg, 177mg (each 3 parts), sets respectively
In 100ml measuring bottle, scale is dissolved and be diluted to methanol respectively, is shaken up, filtered；Precision measures subsequent filtrate 5ml, sets 100ml amount
Bottle in, add methanol solution be diluted to scale to get.
Further, in the Famotidine Capsule in the measuring method of drug content, the detector bar of the HPLC
Flow velocity described in part is 1.5ml/min, and Detection wavelength 270nm, column temperature is 30 DEG C.
The present invention by adopting the above technical scheme, compared with prior art, has the following technical effect that
The measuring method of drug content in Famotidine Capsule of the present invention examines famotidine using high performance liquid chromatography
The uniformity of dosage units of famotidine in capsule, using potassium dihydrogen phosphate/methanol as mobile phase, using methanol as diluent, precise determination
Famotidine solid pharmaceutical preparation content solves and exists in the prior art that detection efficiency is low, detection error is big and accuracy is not high
The problems such as, while important references can be provided to improve detection level cloud test accuracy in famotidine solid pharmaceutical preparation.
Specific embodiment
The present invention provides a kind of measuring method of drug content in Famotidine Capsule, with potassium dihydrogen phosphate and methanol
Mixed solvent is mobile phase, using methanol as diluent, is detected using high performance liquid chromatography (HPLC), Detection wavelength is
270nm.The mixed solvent of the potassium dihydrogen phosphate and methanol is water-soluble by the potassium dihydrogen phosphate that mass percent concentration is 0.125%
Liquid and methanol is by volume (60-80): (35-45) is configured；Preferably, described 0.125% potassium dihydrogen phosphate aqueous solution
It is by volume 70:30 with formaldehyde.The measuring method uses high performance liquid chromatography, efficiently, accurately, reduces error, while can
Important references are provided to improve detection level cloud test accuracy in famotidine solid pharmaceutical preparation.
As an optimal technical scheme, the testing conditions of the HPLC are as follows: chromatographic column: 250 × 4.6mm of C18 column；Stream
Dynamic phase: the mixed solvent of 0.125% potassium dihydrogen phosphate and methanol；Flow velocity: 1.2-1.8ml/min；Detection wavelength: 270nm；Sample introduction
Amount: 15-25 μ l；Column temperature: 26-34 DEG C；Preferably, flow velocity described in the testing conditions of the HPLC is 1.5ml/min, detects wave
A length of 270nm, column temperature are 30 DEG C.
As an optimal technical scheme, the detection method of the HPLC is as follows: (1) preparation of reference substance solution: following the example of
Fourth reference substance about 10mg is not replaced, it is accurately weighed, add methanol to be configured to the solution of 1ml 10ug containing famotidine, both；(2) for examination
The preparation of product solution: precision weighs famotidine solid pharmaceutical preparation fine powder 0.1g, weighed, sets in 100ml measuring bottle, adds methanol dilution extremely
Scale shakes up；Precision measures 1ml, sets in 100ml measuring bottle, adds methanol solution to scale, shakes up, both obtained；(3) measuring method: respectively
Precision measures contrast solution and each 20ul of test solution, injects high performance liquid chromatograph, measures famotidine content.
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention,
But following embodiments are not intended to limit the scope of the invention.
The measurement of drug content in embodiment Famotidine Capsule
(1) reagent is shown in Table 1:
1 reagent source of table
| Title | Manufacturer | Remarks |
| Famotidine Capsule | Upper Hisense's friendship everything medicine company | Lot number -51161001 |
| Famotidine control | Middle inspection institute | - |
| Famotidine raw material | Chongqing Qingyang pharmaceutcal corporation, Ltd | Lot number -0400-130501 |
| Potassium dihydrogen phosphate | China Tech skill (Jiangsu) Co., Ltd forever | It analyzes pure |
| Methanol | Merck company | Chromatographic grade |
(2) testing conditions of HPLC are as follows:
Chromatographic column: 250 × 4.6mm of C18 column；
Mobile phase: the mixed solvent of 0.125% potassium dihydrogen phosphate and methanol；
Flow velocity: 1.5ml/min；
Detection wavelength: 270nm；
Sample volume: 15-25 μ l；
Column temperature: 26-34 DEG C；
System suitability: number of theoretical plate is not less than 1000.
Further, in the Famotidine Capsule in the measuring method of drug content, the detection side of the HPLC
Method is as follows:
(1) preparation of comparison liquid: precision weighs famotidine reference substance about 20mg, sets in 100ml measuring bottle, is dissolved with methanol
And it is diluted to scale, it shakes up；Precision measures 5ml, sets in 100ml measuring bottle, with methanol to scale, shakes up, and 20ul is taken to inject liquid phase
Chromatograph；
(2) preparation of material liquid: precision weighs famotidine raw material about 20mg, sets in 100ml measuring bottle, simultaneously with methanol dissolution
It is diluted to scale, is shaken up；Precision measures 5ml, sets in 100ml measuring bottle, with methanol dilution to scale, shakes up, and 20ul is taken to inject liquid
Chromatography；
(3) precision weighs Famotidine Capsule about 165mg, 171mg, 177mg (each 3 parts), is set in 100ml measuring bottle respectively,
Scale is dissolved and be diluted to methanol respectively, is shaken up, is filtered；Precision measures subsequent filtrate 5ml, sets in 100ml measuring bottle, adds methanol solution
Be diluted to scale to get.
Method validation is ensure content assaying method of the present invention scientific, reasonable, feasible, and inventor has carried out a series of
Experimental study and investigation.The following are the chromatographic conditions of the measuring method of drug content in Famotidine Capsule of the present invention to determine
Afterwards, its experiment for measuring effect is verified.
1, accuracy, precision, specificity experiment
Precision weighs Famotidine Capsule about 165mg, 171mg, 177mg (each 3 parts), is set in 100ml measuring bottle respectively, respectively
Scale is dissolved and be diluted to methanol, is shaken up, and is filtered；Precision measures subsequent filtrate 5ml, sets in 100ml measuring bottle, methanol solution is added to dilute
To scale to get, take 20ul inject liquid chromatograph.It is measured record chromatogram by embodiment chromatographic condition, records chromatography
The peak area at famotidine peak, testing result are shown in Table 1 in figure:
1 accuracy of table, precision, specificity experimental result
The result shows that: the average recovery rate of peak area is 100.2%, RSD 0.31%, shows the accuracy of this method
High, high-specificity, instrument precision are good.
2, the precision of famotidine
Precision weighs famotidine reference substance about 20mg, sets in 100ml measuring bottle, and scale is dissolved and be diluted to methanol, is shaken
It is even；Precision measures 5ml, sets in 100ml measuring bottle, with methanol to scale, shakes up, and 20ul is taken to inject liquid chromatograph；By embodiment
Chromatographic condition is measured record chromatogram, testing result such as table 2:
The precision experiment result of 2 famotidine of table
3, the precision of measuring method
Test liquid: precision weighs famotidine raw material about 25mg, sets in 50ml measuring bottle, is dissolved with methanol and is diluted to quarter
Degree, shakes up；Precision measures 1ml, sets in 100ml measuring bottle, with methanol dilution to scale, shakes up；Precision measures 1ml, sets 100ml amount
In bottle, with methanol dilution to scale, shake up；Precision measures 3ml, sets in 10ml measuring bottle, methanol dilution to scale shakes up, takes
20ul injects liquid chromatograph；It is measured record chromatogram by embodiment chromatographic condition, testing result such as table 3:
3 precision testing result of table
4, quantitative limit is tested
Stock solution: taking famotidine reference substance about 20mg, accurately weighed, sets in 100ml measuring bottle, methanol is added to dissolve and dilute
To scale, shake up.5ml is taken again, is set in 50ml volumetric flask, is added methanol dilution to scale, is shaken up, as stock solution.
Quantitative limit test liquid: it takes stock solution 3ml into 200ml volumetric flask, adds methanol dilution to scale.20ul is taken to inject liquid
Chromatography；It is measured record chromatogram by embodiment chromatographic condition, testing result such as table 4:
4 quantitative limit testing result of table
| Quantitative limit (ng) | 0.3023 |
As can be seen that this method accuracy, precision, specificity meet from above-mentioned each summary sheet and each detection data
Regulation, average recovery rate 100.2%, RSD 0.31%；Comply with standard.This method can apply to measure famotidine
The practice examining of famotidine content in capsule solves and exists in the prior art that detection efficiency is low, detection error is big and quasi-
The problems such as exactness is not high, while can be provided for detection level cloud test accuracy in improvement famotidine solid pharmaceutical preparation important
With reference to.
Specific embodiments of the present invention are described in detail above, but it is merely an example, the present invention is simultaneously unlimited
It is formed on particular embodiments described above.To those skilled in the art, any couple of present invention carries out equivalent modifications and
Substitution is also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by equal transformation and
Modification, all should be contained within the scope of the invention.
Claims (7)
1. the measuring method of drug content in a kind of Famotidine Capsule, which is characterized in that with the mixed of potassium dihydrogen phosphate and methanol
Bonding solvent is mobile phase, using methanol as diluent, is detected using high performance liquid chromatography (HPLC), Detection wavelength is
270nm。
2. the measuring method of drug content in Famotidine Capsule according to claim 1, which is characterized in that the phosphoric acid
The potassium dihydrogen phosphate aqueous solution and methanol that the mixed solvent of potassium dihydrogen and methanol is 0.125% by mass percent concentration press volume
Than (60-80): (35-45) is configured.
3. the measuring method of drug content in Famotidine Capsule according to claim 2, which is characterized in that described
0.125% potassium dihydrogen phosphate aqueous solution and formaldehyde is 60:80 by volume.
4. the measuring method of drug content in Famotidine Capsule according to claim 1, which is characterized in that the HPLC
Testing conditions it is as follows:
Chromatographic column: 250 × 4.6mm of C18 column；
Mobile phase: the mixed solvent of 0.125% potassium dihydrogen phosphate and methanol；
Flow velocity: 1.2-1.8ml/min；
Detection wavelength: 270nm；
Sample volume: 15-25 μ l；
Column temperature: 26-34 DEG C；
System suitability: number of theoretical plate, which is pressed, is not less than 1000.
5. the measuring method of drug content in Famotidine Capsule according to claim 1, which is characterized in that the HPLC
Detection method it is as follows:
(1) preparation of reference substance solution: taking famotidine reference substance about 10mg, accurately weighed, adds methanol to be configured to 1ml and contains method not
For the solution of fourth 10ug, both；
(2) preparation of test solution: precision weighs famotidine solid pharmaceutical preparation fine powder 0.1g, weighed, sets in 100ml measuring bottle,
Add methanol dilution to scale, shakes up；Precision measures 1ml, sets in 100ml measuring bottle, adds methanol solution to scale, shakes up, both obtained；
(3) measuring method: it is accurate respectively to measure contrast solution and each 20ul of test solution, inject high performance liquid chromatograph, measurement
Famotidine content.
6. the measuring method of drug content in Famotidine Capsule according to claim 5, which is characterized in that the method is not
For the methanol solution preparation method of fourth are as follows: precision weighs Famotidine Capsule about 165mg, 171mg, 177mg (each 3 parts), respectively
It sets in 100ml measuring bottle, dissolves and be diluted to scale with methanol respectively, shake up, filter；Precision measures subsequent filtrate 5ml, sets 100ml
In measuring bottle, add methanol solution be diluted to scale to get.
7. the measuring method of drug content in Famotidine Capsule according to claim 1, which is characterized in that the HPLC
Testing conditions described in flow velocity be 1.5ml/min, Detection wavelength 270nm, column temperature be 30 DEG C.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110988169A (en) * | 2019-12-12 | 2020-04-10 | 南京正济医药研究有限公司 | High performance liquid chromatography analysis and detection method for formaldehyde content in ranitidine hydrochloride |
| CN112763625A (en) * | 2020-12-30 | 2021-05-07 | 江苏正济药业股份有限公司 | Detection method of famotidine and related substances thereof |
| CN114791469A (en) * | 2022-04-25 | 2022-07-26 | 四川启源药业有限公司 | Method for detecting content of vitamin C in famotidine injection |
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Cited By (3)
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| CN110988169A (en) * | 2019-12-12 | 2020-04-10 | 南京正济医药研究有限公司 | High performance liquid chromatography analysis and detection method for formaldehyde content in ranitidine hydrochloride |
| CN112763625A (en) * | 2020-12-30 | 2021-05-07 | 江苏正济药业股份有限公司 | Detection method of famotidine and related substances thereof |
| CN114791469A (en) * | 2022-04-25 | 2022-07-26 | 四川启源药业有限公司 | Method for detecting content of vitamin C in famotidine injection |
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