Study On The Quality Standards Of Ketoprofen/Omeprazole Modified-release Capsules

Objective:1.Establishing a method for determination the content of ketoprofen/omeprazole modified-release capsules;2.Establishing a method for determination the dissolution of ketoprofen/omeprazole modified-release capsules,and compared the dissolution curve between self--made samples and reference drug products;3.To study the related substance of ketoprofen sustained-release pellets and omeprazole enteric-coated pellets;4.Establishing the quality standard of ketoprofen/omeprazole modified-release capsules.Methods:1.To determine the content of ketoprofen/omeprazole modified-release capsules using HPLC method;2.To determine the dissolution using basket method 100 rpm.using hydrochloric acid solution and then buffer as dissolution medium,using HPLC method as test method,to compare the dissolution curve between self-made samples and reference drug products using a variety of media;3.To determine the related substances of ketoprofen sustained-release pellets and omeprazole enteric-coated pellets using HPLC method;4.Preliminary stability study was carried out.Results:1.In assay test.the linear range of ketoprofen is 139.93?g·ml-1?259.87?g·ml-1,r=0.9999.the intermediate precision RSD is 1.01%(n=12).the mean recovery is 98.6%;the linear range of omeprazole is 14.08?g·ml-1?26.14?g·ml-1,r=0.9998.the intermediate precision RSD is 0.97%(n=12),the mean recovery is 99.5%..2.In dissolution test.ketoprofen has good linear within the concentration range of 2.29?g·ml-1?229.09?g·ml-1.r=1.0000,the mean recovery is 98.5%.the intermediate precision RSD is 1.03%(n=12);omeprazole has good linear within the concentration range of 0.24?g·ml-1?23.62?g·ml-1 r=0.9999;the mean recovery is 99.3%,the intermediate precision RSD is 1.67%(n=12);the f2 factor between self-made samples and reference drug products is more than 50.3.In different dissolution media.The change of mobile phase,column temperature and column will not affect the test result of related substances of ketoprofen sustained-release pellets,ketoprofen and its impurities have good resolution,excipients have no interfere to the test,good recovery and linear of ketoprofen and seven of its known impurities.4,The change of mobile phase,column temperature and column will not affect the test result of related substances of omeprazole enteric-coated pellets,omeprazole and its impurities have good resolution,excipients have no interfere to the test,good recovery and linear of omeprazole and six of its known impurities.5.According to the stability research results,the storage condition was formulated.Conclusion:1.The established assay method has good specificity,reproducibility and robustness with short detection time,it's accurate and reliable.2.The established dissolution method is simple to operate;the test result is accurate and reliable;it suitable for the requirement of both enteric coated and sustained-release drug form;the dissolution activity of batches of self-made samples is in accordance with commercial drug products in different dissolution media,which provided the preliminary ensurance for in vivo bioavailability consistency.3.Both of the related substances test methods of ketoprofen sustained-release pellets and omeprazole enteric-coated pellets have good specificity,reproducibility and high sensitivity,it's simple and accurate and suitable for related substances of ketoprofen sustained-release pellets.4.The quality standard can reflect the change of the quality of goods,provides effective analysis standard for quality control of ketoprofen/omeprazole modified-release capsules.