盐酸曲美他嗪择时渗透泵控释片的制备及含量测定

Preparation and Determination of Trimetazidine Dihydrochloride Pulsatile Osmotic Pump Controlled Release Tablets

目的:建立盐酸曲美他嗪择时渗透泵控释片中盐酸曲美他嗪的高效液相色谱含量测定方法。方法:采用Dikma Diamonsil C_(18)色谱柱(250 mm×4.6 mm,5μm),以0.02 mol·L^(-1)乙酸铵(含0.5%三乙胺)-甲醇(50:50)为流动相,流速为1.0 ml·min^(-1),检测波长为232 nm.进样量20μl。结果:在此色谱条件下,盐酸曲美他嗪浓度与峰面积在6.0~16.8μg·ml^(-1)内线性关系良好,r=0.999 5,平均回收率为99.6%,RSD为1.04%(n=9)。结论:本方法灵敏度高,快速准确,可用于盐酸曲美他嗪择时控释片的质量控制。

Objective;To eslablish an HPLC method for the determination of trimetazidine dihydrochloride pulsatile controlled release tablets.Method：A Dikma Diamonsil C18 column（250 mm×4.6 mm,5μm）was used,the mobile phase consisted of0.02 mol ？ L-1 ammonium acetate（including 0.5%triethylamine）-methanol（50：50） with a flow rate of 1.0 ml？min-1,the detection wavelength was 232nm,and the injection volume was 20μl.Result：The linear range of trimetazidine dihydrochloride was 6.0-16.8 μg？ ml-1（r=0.999 5）.The recovery was 99.6%with RSD of 1.04%（n =9）.Conclusion;The method is sensitive,rapid and accurate,and can be used in the quality control of trimetazidine dihydrochloride pulsatile controlled release tablets.