复方奥美拉唑胶囊的制备和质量控制

Study on Preparation and Quality Control Method of Compound Omeprazole Capsule

目的探讨复方奥美拉唑胶囊的制备及其质量控制方法。方法制备处方中加入抗酸剂碳酸氢钠;含量测定采用高效液相色谱法,色谱柱为C18柱(150 mm×4.6 mm,5μm),以磷酸盐缓冲液(0.02 mol/L磷酸二氢钾,pH=4.5)-乙腈(70∶30,V/V)为流动相,流速1.0 mL/min,检测波长302 nm。结果奥美拉唑质量浓度在5.0～15.0μg/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率和RSD分别为100.34%和0.55%,3批样品含量分别为标示量的99.7%,99.3%,99.7%。结论所用方法简单,易于操作;含量测定方法简便、准确、回收率高,可用于复方奥美拉唑胶囊的质量控制。

Objective To research the preparation and quality control method of Compound Omeprazole Capsule.Methods Adding anti-acid agent sodium hydrogen carbonate in the prescription,HPLC was used for the content determination of omeprazole.The chromatographic procedure was carried out using Zorbax ODS C18 column（150 mm×4.6 mm,5 μm） as the analytic column and the mixture of 0.02 mol/L potassium dihydrogen phosphate（pH=4.5）-acetonitrile（70 ∶30,V/V）as the mobile phase at the flow rate of 1.0 mL/min.The detection wavelength was set at 302 nm.Results The linear range of Compound Omeprazole Capsules was 5.0-15.0 μg/mL（r=0.999 9）.In the three batches of samples,the average recovery rate and RSD value of omeprazole were 100.34%and 0.55%respectively.The content of the three batches of samples were 99.7%,99.3%and 99.7%respectively.Conclusion This preparation method is simple and easy to be operated.The content determination method is accurate and simple with high recovery rate,which can be used for the quality control of Compound Omeprazole Capsules.