盐酸吡咯列酮口服固体制剂中有关物质测定方法的研究及产品评价

The Related Substances Research and Product Evaluation for Pioglitazone Hydrochloride Oral Solid Dosage Form

目的:综合对比评价现行盐酸吡咯列酮产品有关物质质量标准,建立一种完善的有关物质测定方法。方法:采用HPLC及HPLC-MS/MS等方法进行检测,对原料及制剂中的杂质进行了分析及相关的比较研究。结果:现行质量标准存在一定问题;制剂中的杂质与原料生产工艺有一定相关性。结论:新建方法专属性强,灵敏度高,能够更为客观的评价不同产品中的杂质水平,可满足产品的质量控制要求。

Objective: To compare and evaluate the existing methods for the related substances of pioglitazone hydrochloride quality standards,and to establish a more successful determination for them.Methods: Using HPLC and HPLC-MS/MS as detection methods for analyzing the impurities in raw material and preparations.Results: There are some certain problems in existing quality standards;the impurities in preparations have a certain relation with the production process of raw materials.Conclusion: This method is specific and sensitive,also more objective for assessing the level of impurities in different products,thus it could be fully met the products quality control requirement.