高效液相色谱法测定辛伐他汀分散片的含量及其有关物质

Determination of simvastatin and its related substances in simvastatin dispersible tablets by HPLC

目的:采用高效液相色谱法测定辛伐他汀分散片中辛伐他汀及其有关物质的含量。方法:色谱柱ODS-C18柱(250mm×4.6mm,5μm);以乙腈-0.025mol.L-1磷酸二氢钠溶液(pH4.5)(65∶35)为流动相;检测波长为238nm。结果:回归方程A=48 504.5C-31.57,线性范围为1.108×10-3~1.772×10-1g.L-1(r=0.999 6),含量测定的平均回收率为99.14%,RSD为0.37%(n=9)。结论:方法重现性好,准确度高,适于辛伐他汀片剂的质量控制。

OBJECTIVE HPLC method was described to determine simvastatin and its related substances in simvastatin dispersible tablets. METHODS ODS-C18 column （250 mm × 4. 6 mm,5 μm） ;acetonitrile：0. 025 mol·L^-1 sodium phosphate mono basic（pH 4. 5）（65：35） as mobile phase^detector wavelength 238 nm. RESULTS Calibration curve was linear over the range of 1. 108 × 10^-3 - 1.772 × 10^-1 g·L^-1 （r= 0. 999 6） ; for potency assay the mean recovery was 99. 14% with RSD as 0. 37% （n = 9）. CONCLUSION The method is sensitive,accurate and rapid. It is suitable for quality control of simvastatin dispersible tablets.