HPLC同时测定依折麦布辛伐他汀片中两种成分的含量

Simultaneous Determination of Two Constituents in Ezetimibe and Simvastatin Tablets by HPLC

关键词:  依折麦布  辛伐他汀  高效液相色谱法  含量测定

Key words:  ezetimibe  simvastatin  HPLC  determination

摘要:

目的 建立高效液相色谱法同时测定依折麦布辛伐他汀片中依折麦布和辛伐他汀的含量。方法 色谱柱Phenomenex Luna Phenyl Hexyl(4.6 mm×150 mm，5 μm)，以乙腈-0.02 mol·L^-1磷酸二氢钠(pH 4.5)为流动相，梯度洗脱，流速1.0 mL·min^-1，检测波长231 nm，柱温30 ℃。结果 依折麦布在10.0~100.0 μg·mL^-1内线性关系良好(r=0.999 8)，辛伐他汀在20.0~200.0 μg·mL^-1内线性关系良好(r=0.999 9)。依折麦布的平均回收率为99.5%，RSD为1.3%(n=9)，辛伐他汀的平均回收率为99.8%，RSD为0.9%(n=9)。结论 本方法简便、可靠、准确度高、重复性好，可用于同时测定依折麦布辛伐他汀片中的依折麦布和辛伐他汀的含量。

Abstract:

OBJECTIVE To establish an HPLC method for simultaneous determination of ezetimibe and simvastatin in ezetimibe and simvastatin tablets. METHODS The chromatographic separation was achieved on a Phenomenex Luna Phenyl Hexyl column(4.6 mm×150 mm, 5 μm) with acetonitrile-0.02 mol·L^-1 sodium dihydrogen phosphate (pH 4.5) as mobile phase, gradient elution, at the flow rate of 1.0 mL·min^-1. The detective wavelength was 231 nn and the temperature of column was 30 ℃. RESULTS The calibration curves of ezetimibe and simvastatin were linear in the range of 10.0-100.0 μg·mL^-1(r=0.999 8), 20.0-200.0 μg·mL^-1(r=0.999 9), respectively. The average recoveries of ezetimibe and simvastatin were 99.5%, RSD=1.3%(n=9) and 99.8%, RSD=0.9%(n=9), respectively. CONCLUSION The method is simple, reliable and accurate for simultaneous determination of ezetimibe and simvastatin in ezetimibe and simvastatin tablets.