Liquid chromatographic analysis method for parecoxib-sodium related substances

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...

AI Technical Summary

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

Images