CN104407063A - Method for determining content of ceftriaxone sodium for injection - Google Patents
Method for determining content of ceftriaxone sodium for injection Download PDFInfo
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- CN104407063A CN104407063A CN201410482727.8A CN201410482727A CN104407063A CN 104407063 A CN104407063 A CN 104407063A CN 201410482727 A CN201410482727 A CN 201410482727A CN 104407063 A CN104407063 A CN 104407063A
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Abstract
The invention discloses a method for determining content of oceftriaxone sodium for injection. The method includes the steps of: preparing a dipotassium hydrogen phosphate and potassium dihydrogen phosphate buffer solution with pH value of 7.0, preparing a sodium citrate buffer solution with pH value of 5.0; then preparing a resolution solution, taking 4 mg of ceftriaxone sodium reference substance and 4mg of a ceftriaxone sodium E-isomer reference substance, dissolving with a mobile phase and diluting to 25.0 mL, preparing a reference solution and a test solution, and determining the content. The invention has the advantages of reliability, accuracy, system suitability and specificity, and can meet the demand of detection stability.
Description
Technical field
The present invention relates to field of medicaments, particularly, relate to a kind of method measuring ceftriaxone for inj content.
Background technology
Ceftriaxone Sodium be novel, be in great demand, the third generation semi-synthetic cephalosporins microbiotic of wide spectrum.This medicine is semisynthetic third generation cephalosporin, have powerful antibacterial activity to most of gram positive bacteria and negative bacterium, antimicrobial spectrum comprises Pseudomonas aeruginosa, Escherichia coli, pneumobacillus, haemophilus influenzae, aerogenesis enterobacteria, Proteus, Diplococcus and S. aureus L-forms etc.This medicine is stablized beta lactamase.Clinical be mainly used in sensitive bacteria infect meningitis, pneumonia, skin soft-tissue infection, peritonitis, urinary system infection contamination, gonorrhoea, liver and gall infect, surgery wound, septicemia and genital infection etc.As the First Line medicine for the treatment of gonorrhoea.
In commercial production, need the content measuring ceftriaxone preparation of sodium to control the quality of ceftriaxone preparation of sodium, therefore need the content assaying method of ceftriaxone preparation of sodium.Existing assay method does not have the instruction ability of stability, and therefore assay method is always accurately unreliable, can not meet the durability requirements of detection.
Summary of the invention
Technical matters to be solved by this invention is to provide a kind of method measuring ceftriaxone for inj content, and the method is reliable accurately, have system suitability, specificity, can meet the durability requirements of detection.
The present invention's adopted technical scheme that solves the problem is:
Measure the method for ceftriaxone for inj content, comprise the following steps:
(1) prepare pH be 7.0 dipotassium hydrogen phosphate and potassium phosphate buffer, preparation pH be the sodium citrate buffer solution of 5.0; Take octadecylsilane chemically bonded silica as Stationary liquid, using four heptyl ammonium bromides be placed in acetonitrile add pH be 7.0 damping fluid and pH be 5.0 damping fluid again dilute with water and filter after as mobile phase;
(2) degree of separation solution is prepared: get Ceftriaxone Sodium reference substance and each 4mg of Ceftriaxone Sodium E-isomer control product, dissolve with mobile phase and be diluted to 25.0mL;
(3) reference substance solution and solution to be measured is prepared;
(4) content is measured: first sample introduction degree of separation solution, degree of separation >=3.0 of Ceftriaxone Sodium E-isomeride and Ceftriaxone Sodium; Sample introduction reference substance solution again, controls relative standard deviation≤2% repeating sample introduction; Sample introduction reference substance solution and need testing solution again, then according to formula: 200(CP/W) (ru/rs), wherein, C is the concentration of Ceftriaxone Sodium reference substance in reference substance solution; P is the definition concentration of ceftriaxone in Ceftriaxone Sodium reference substance; W is the weight of sample in solution to be tested; Ru and rs is respectively main peak response in need testing solution and reference substance solution.
Described reference substance solution gets Ceftriaxone Sodium reference substance 20mg, dissolves and be diluted to 25mL with mobile phase.Testing sample 40mg is got in being formulated as of described solution to be measured, is placed in 200mL measuring bottle, dissolves and be diluted to scale with mobile phase.
Also comprise specificity to measure: sample introduction blank solution and degree of separation solution, blank has purity and the peak-to-peak degree of separation of chromatogram of noiseless, chromatographic peak to utilize diode array detector to check.
To sum up, the invention has the beneficial effects as follows:
The method of the present invention is reliable accurately, have system suitability, specificity, can meet the durability requirements of detection.
Embodiment
Below in conjunction with embodiment, to the detailed description further of the present invention's do, but embodiments of the present invention are not limited thereto, and any unsubstantiality made embodiments of the invention simply changes or replaces, and all answers within the scope of the invention involved.
Embodiment 1:
Need the equipment used: diode array detector, chromatographic column C18, pH meter, Ceftriaxone Sodium reference substance is from USP pharmacopoeia commission, and Ceftriaxone Sodium E-isomeride, from USP pharmacopoeia commission.Determined wavelength 270nm;
Measure the method for ceftriaxone for inj content, comprise the following steps:
(1) prepare pH be 7.0 dipotassium hydrogen phosphate and potassium phosphate buffer, preparation pH be the sodium citrate buffer solution of 5.0; Take octadecylsilane chemically bonded silica as Stationary liquid, using four heptyl ammonium bromides be placed in acetonitrile add pH be 7.0 damping fluid and pH be 5.0 damping fluid again dilute with water and filter after as mobile phase; Need be the damping fluid of 7.0 ± 0.1 with phosphoric acid or 10N potassium hydroxide solution adjustment pH, the pH of the damping fluid of citric acid solution adjustment pH5.0 be 5.0 ± 0.1.
(2) degree of separation solution is prepared: get Ceftriaxone Sodium reference substance and each 4mg of Ceftriaxone Sodium E-isomer control product, dissolve with mobile phase and be diluted to 25.0mL;
(3) reference substance solution and solution to be measured is prepared;
(4) content is measured: first sample introduction degree of separation solution, degree of separation >=3.0 of Ceftriaxone Sodium E-isomeride and Ceftriaxone Sodium; Sample introduction reference substance solution again, controls relative standard deviation≤2% repeating sample introduction; Sample introduction reference substance solution and need testing solution again, then according to formula: 200(CP/W) (ru/rs), wherein, C is the concentration of Ceftriaxone Sodium reference substance in reference substance solution; P is the definition concentration of ceftriaxone in Ceftriaxone Sodium reference substance; W is the weight of sample in solution to be tested; Ru and rs is respectively main peak response in need testing solution and reference substance solution.
Described reference substance solution gets Ceftriaxone Sodium reference substance 20mg, dissolves and be diluted to 25mL with mobile phase.Testing sample 40mg is got in being formulated as of described solution to be measured, is placed in 200mL measuring bottle, dissolves and be diluted to scale with mobile phase.
Also comprise specificity to measure: sample introduction blank solution and degree of separation solution, blank has purity and the peak-to-peak degree of separation of chromatogram of noiseless, chromatographic peak to utilize diode array detector to check.
Claims (4)
1. measure the method for ceftriaxone for inj content, it is characterized in that, comprise the following steps:
Preparation pH be 7.0 dipotassium hydrogen phosphate and potassium phosphate buffer, preparation pH be the sodium citrate buffer solution of 5.0; Take octadecylsilane chemically bonded silica as Stationary liquid, using four heptyl ammonium bromides be placed in acetonitrile add pH be 7.0 damping fluid and pH be 5.0 damping fluid again dilute with water and filter after as mobile phase;
Preparation degree of separation solution: get Ceftriaxone Sodium reference substance and each 4mg of Ceftriaxone Sodium E-isomer control product, dissolve with mobile phase and be diluted to 25.0mL;
Preparation reference substance solution and solution to be measured;
Measure content: first sample introduction degree of separation solution, degree of separation >=3.0 of Ceftriaxone Sodium E-isomeride and Ceftriaxone Sodium; Sample introduction reference substance solution again, controls relative standard deviation≤2% repeating sample introduction; Sample introduction reference substance solution and need testing solution again, then according to formula: 200(CP/W) (ru/rs), wherein, C is the concentration of Ceftriaxone Sodium reference substance in reference substance solution; P is the definition concentration of ceftriaxone in Ceftriaxone Sodium reference substance; W is the weight of sample in solution to be tested; Ru and rs is respectively main peak response in need testing solution and reference substance solution.
2. the method for mensuration ceftriaxone for inj content according to claim 1, is characterized in that, described reference substance solution gets Ceftriaxone Sodium reference substance 20mg, dissolves and be diluted to 25mL with mobile phase.
3. the method for mensuration ceftriaxone for inj content according to claim 1, is characterized in that, testing sample 40mg is got in being formulated as of described solution to be measured, is placed in 200mL measuring bottle, dissolves and be diluted to scale with mobile phase.
4. the method for mensuration ceftriaxone for inj content according to claim 1, it is characterized in that, also comprise specificity to measure: sample introduction blank solution and degree of separation solution, blank has purity and the peak-to-peak degree of separation of chromatogram of noiseless, chromatographic peak to utilize diode array detector to check.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410482727.8A CN104407063A (en) | 2014-09-21 | 2014-09-21 | Method for determining content of ceftriaxone sodium for injection |
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| CN201410482727.8A CN104407063A (en) | 2014-09-21 | 2014-09-21 | Method for determining content of ceftriaxone sodium for injection |
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| CN104407063A true CN104407063A (en) | 2015-03-11 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106093263A (en) * | 2016-07-01 | 2016-11-09 | 山东润泽制药有限公司 | A kind of ceftriaxone sodium for injection method of quality control |
| CN109932433A (en) * | 2017-12-15 | 2019-06-25 | 湖南千金协力药业有限公司 | The measuring method of levels of toxic substances in a kind of Zinc calcium gluconate oral solution |
| CN110596274A (en) * | 2019-09-29 | 2019-12-20 | 山东鲁抗医药股份有限公司 | Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium |
-
2014
- 2014-09-21 CN CN201410482727.8A patent/CN104407063A/en active Pending
Non-Patent Citations (2)
| Title |
|---|
| 欧洲药典委员会: "《欧洲药典》", 31 July 2010 * |
| 美国药典委员会: "《USP35-NF30》", 1 May 2012 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106093263A (en) * | 2016-07-01 | 2016-11-09 | 山东润泽制药有限公司 | A kind of ceftriaxone sodium for injection method of quality control |
| CN109932433A (en) * | 2017-12-15 | 2019-06-25 | 湖南千金协力药业有限公司 | The measuring method of levels of toxic substances in a kind of Zinc calcium gluconate oral solution |
| CN110596274A (en) * | 2019-09-29 | 2019-12-20 | 山东鲁抗医药股份有限公司 | Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium |
| CN110596274B (en) * | 2019-09-29 | 2022-03-18 | 山东鲁抗医药股份有限公司 | Method for detecting 2-mercaptobenzothiazole in ceftriaxone sodium |
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Application publication date: 20150311 |