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A liquid chromatography analysis method for related substances of parecoxib sodium

A technology of liquid chromatography analysis and parecoxib sodium, which is applied in the direction of analyzing materials, material separation, measuring devices, etc., can solve the problems of relying on instruments, complex research, and inability to accurately and effectively quantitatively detect impurities, so as to reduce detection costs Effect

Active Publication Date: 2017-03-29
SHANGHAI CHENPON PHARM TECH CO LTD
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Problems solved by technology

[0004] Although parecoxib sodium can now be produced on a large scale, the analysis and detection methods for related substances of parecoxib sodium still rely on sophisticated instruments and complex research
However, an existing analysis method in the import registration standard of Parecoxib Sodium for Injection found in the test of detecting related substances of Parecoxib Sodium that this method could not effectively separate certain impurities, nor could it accurately and effectively quantify Detecting these potential impurities, let alone guarantee the quality of the drug

Method used

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  • A liquid chromatography analysis method for related substances of parecoxib sodium
  • A liquid chromatography analysis method for related substances of parecoxib sodium
  • A liquid chromatography analysis method for related substances of parecoxib sodium

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Embodiment 1

[0033] Step 1: System suitability test: (1) Take the reference substances of impurity Ⅰ, impurity Ⅱ, impurity Ⅲ, impurity Ⅳ, impurity Ⅴ, impurity Ⅵ and parecoxib sodium respectively, and acetonitrile aqueous solution (volume ratio 40:60) Dilute to a mixed solution containing 1 mg of parecoxib sodium, 1.5 μg of impurity I, 1.5 μg of impurity II, 1.5 μg of impurity III, 1.5 μg of impurity IV, 1.5 μg of impurity V, and 1.5 μg of impurity VI per ml, as a system suitability solution (2) Set the liquid chromatograph, wherein the chromatographic column is a 100mm × 4.6mm silica gel column, and the built-in C18 core-shell technology is bonded with pentafluorophenyl filler, and the particle size of the filler is 2.6 μm, and the liquid chromatograph The detection wavelength of the instrument is 230nm, water-methanol-trifluoroacetic acid (volume ratio is preferably 10:90:0.05) as mobile phase A, water-methanol-trifluoroacetic acid (volume ratio is preferably 90:10:0.05) For mobile phase ...

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Abstract

The invention provides a liquid chromatographic analysis method for parecoxib-sodium related substances. The liquid chromatographic analysis method comprises the following contents: 1. system-applicability experiment: (1) respectively taking contrast products of all impurities and parecoxib sodium, and diluting, wherein the obtained diluent is taken as system-applicability solution; (2) setting a liquid chromatograph, injecting the system-applicability solution into the liquid chromatograph, and recording a chromatogram till the separation degree among all peaks conforms to the specification; 2. determination experiment: (1) taking the parecoxib sodium to be tested and placing in a container, adding a solvent to dissolve and dilute, wherein the obtained diluent is taken as a test-article solution; (2) taking the test-article solution, and diluting, wherein the obtained diluent is taken as a contrast solution; (3) respectively taking and injecting the test-article solution and the contrast solution into the liquid chromatograph, and recording a chromatogram; and (4) calculating by a self-contrast method according to the peaks in the chromatogram of the test-article solution. The liquid chromatographic analysis method provided by the invention has the advantages that the trace potential impurities in the parecoxib sodium can be accurately detected in a high-efficiency and low-cost manner, and good quality guarantee can be provided; and the liquid chromatographic analysis method also can be used for detecting and analyzing other substances.

Description

technical field [0001] The invention relates to an analysis method, in particular to a liquid chromatography analysis method for related substances of parecoxib sodium. Background technique [0002] Parecoxib Sodium (Parecoxib Sodium) is the first COX-2 inhibitor for injection, which can be used for the treatment of moderate to severe acute pain after surgery. Its clinical curative effect has been confirmed in the analgesic treatment after various operations such as stomatology, gynecology, orthopedics, and postoperative intravenous administration of this product can reduce the dosage of morphine, thereby improving the quality of postoperative analgesia. [0003] Due to its unique advantages, the application range of parecoxib sodium is constantly expanding, wherein, CN104250232 discloses a preparation method of parecoxib sodium, the method is based on 3,4-diphenyl-5-methyl Based on isoxazole as raw material, after sulfonation, aminolysis, acylation, salt formation and recr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
Inventor 吴浩亮杜狄峥罗瑞昌严宏营王俊琪
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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