Objective To determine the impurities in 115 batches of mesalazine enteric-coated tablets from 3 domestic manufacturers,and to conduct preliminary qualitative and source analysis of the main impurities.Methods The related impurities were quantitatively and qualitatively analyzed by liquid chromatography(LC)and LC-MS.The water content of samples containing specific impurities was determined by Fisher's method.The correlation between the impurities and water was studied.Results Totally 4 main impurities were detected.Impurities 1,2 and 4 were the specific impurities of the sample produced by enterprise 1,among which impurities 1 and 2 were the impurities produced by the reaction between the auxiliary materials and the raw materials in the prescription.Impurity 4 was a hydrolyzed impurity,and excipients in the prescription promoted the production of impurity 4.Impurity 3 was impurity G in the European Pharmacopoeia,which was detected in all samples from 3 companies.Conclusion The related impurities in mesalazine enteric-coated tablets in different prescriptions vary,and the raw materials in the prescription of enterprise 1 are incompatible,so enterprise 1 should modify related prescription.
关键词
美沙拉秦(嗪)肠溶片/处方/杂质/原辅料相容性
Key words
mesalazine enteric-coated tablet/prescription/impurity/compatibility of raw and auxiliary material
维普
万方数据