HPLC法测定拉呋替丁胶囊含量及有关物质

摘要

Objective To establish a method for determination of lafutiding capsules and its related substances. Method The column was Agilent ZORAX Eclipse XDB C18 column( 150 mm x4. 6 mm,5 μm ). The mobile phase was methanol-1% ammonium acetate solution ( pH adjusted to 5. 7 with glacial acetic acid )( 40:60 ). The flow-rate was 1.0 ml · Min-1 , and the detection wavelength was 279 nm. Results The calibration curves of lafutiding was 10. 12 ~ 506 mg · L-1 ( r =0. 999 9 ),the average recovery rate was 100. 75 % and RSD was 0. 67% . Conclusion The method is sensitive,accurate and rapid, which can be used to determine the content of lafutiding capsules and its related substances.%目的 建立HPLC法测定拉呋替丁胶囊含量及有关物质.方法 用Agilent ZORAX Eclipse XDB C18 (150 mm×4.6 mm,5 μm),以甲醇-1%醋酸铵溶液(冰醋酸调节pH为5.7)(40:60)为流动相,流速为1.0 ml·min-1,检测波长为279 nm.结果 拉呋替丁线性范围为10.12～506 mg·L-1(r=0.999 9);平均回收率为100.75 %,RSD为0.67 %.结论 该方法灵敏,快速,结果准确,可用于拉呋替丁胶囊的质量控制.