复方奥美拉唑胶囊的质量标准

Study on Quality Control Methods of Compound Omeprazole Capsule

目的建立复方奥美拉唑胶囊质量标准。方法采用薄层色谱法鉴别胶囊中的白及;含量测定采用反相高效液相色谱法(RP-HPLC):色谱柱为C18柱(150mm×4.6mm,5μm),以乙腈-磷酸盐缓冲液(0.02mol·L-1磷酸二氢钾,pH4.5)(30∶70,V/V)为流动相;流速:1.0ml/min;检测波长302nm;灵敏度AuFs0.08。结果复方奥美拉唑胶囊内容物薄层色谱与对照药材白及基本一致。奥美拉唑保留时间为12.24min,且与其它峰的分离度>1.5,线性范围为0.00854～0.0854mg·ml-1(r=0.9999),奥美拉唑的最低检测限和最低定量限分别为1.7ng和6.4ng,平均回收率和RSD分别为102.25%和1.75%。结论所用方法准确性高,操作简单,可为该制剂的质量控制提供依据。

Aim To establish a quality standard for Compound Omeprazole Capsule. Methods Thin layer chromatography（TLC） was used to determine Rhizoma Bletillae in Compound Omeprazole Capsule. RP-HPLC was used for the determination of omeprazole. The chromatographic procedure was carried out using Zorbax ODS Cls （ 150mm × 4.6mm, 5um） as an analytic column and a mixture of 30 volume of acetonitrile, 70 volume of 0.02mol.L^-1 potassium dihydrogen phosphate as a mobile phase at a flow rate of 1.0ml/min. The detection wavelength was set at 302nm. Results TLC chromatogram of Compound Omeprazole Capsule content was same as that of Rhizoma Bletillae. The ta of omeprazole was about 12.24 minutes. Resolution between omeprazole and other peaks exceeded 1.5 and its linear range was between 0.008 54mg.ml^-1 and 0.085 4mg.ml^-1 （r =0. 9999）. The detection limit was 1.7ng and the quantitation limit was 6.4 ng. The average recovery rate and RSD value of omeprazole were 102.25% and 1.75%, respectively. Conclusion This method is sensitive and quick and can be used for quality asses went of Compound Omeprazole Capsule.