复方奥美拉唑胶囊的质量标准研究

Study on Quality Standards of Compound Omeprazole Capsules

目的:制定自制复方奥美拉唑胶囊的质量标准。方法:采用HPLC法进行含量测定,采用HPLC法、化学法进行定性鉴别。结果:样品经酸、碱、氧化、高温、光照破坏后所产生的杂质峰均能与主峰有效分离,奥美拉唑在12.3～28.7μg/mL的范围内线性关系良好,回归方程为:C=48 146A+4243.8,r=0.999 9;平均回收率为99.53%,RSD为0.42%。结论:该质量控制方法准确,稳定性良好,可用于复方奥美拉唑胶囊的质量评价。

Objective：To establish the quality standards of Compound Omeprazole Capsules.Methods：Compound Omeprazole Capsules were identified by HPLC and chemical method.The content of Compound Omeprazole Capsules were determined by HPLC.Results：The HPLC standard curve was linear within the concentration range of 12.3~28.7μg/mL for omeprazole,the linear equation was C=48 146A＋4 243.8,r=0.999 9.The recovery rate was 99.53%,RSD was 0.42%.Conclusion：The quatily control method of omprazole is accurate and stable.It can be used for the quality appraisal of Compound Omeprazole Capsules.