高效液相色谱法测定人血浆中匹伐他汀浓度

HPLC determination of pitavastatin in human plasma

目的:建立以高效液相色谱法测定匹伐他汀血药浓度的方法。方法:分析柱为岛津VP-ODS(250mm×4.6mm,5μm),流动相为乙腈-30mmol.L-1磷酸二氢钾缓冲盐溶液-三乙胺(醋酸调pH=4.0)(43∶57∶0.1),流速为1.0mL.min-1,检测波长为244nm。结果:匹伐他汀在0.832～106.5μg.L-1检测浓度范围内呈良好线性关系(r=0.9998),最低定量限为0.832μg.L-1。高、中、低3种浓度的日内和日间RSD<8%。结论:该方法操作简便、灵敏、准确,适用于临床匹伐他汀的血药浓度监测及其药动学研究。

Objective：To establish an HPLC method for determination of pitavastatin in human plasma. Methods：Analytical column was Shimadzu VP-ODS（250 mm×4.6 mm,5 μm）.The mobile phase consisted of acetonitrile-30 mmol·L-1 potassium dihydrogen phosphate-triethylamine （adjusting to pH4.0 with acetic acid） （43：57：0.1） with a flow rate of 1.0 mL·min-1.The detection was performed at UV 244 nm. Results：The calibration curve was linear in the concentrations ranging from 0.832 to 106.5 μg·L-1（r=0.9998）.The lower limit of qualification was 0.832 μg·L-1.The intra-day and inter-day RSD were less than 8%. Conclusion：The method is simple,sensitive,accurate and suitable for determination of pitavastatin in human plasma and pharmacokinetic study.