LC-MS测定人血浆中匹伐他汀浓度及其应用

目的建立LC-MS测定人血浆中匹伐他汀的浓度。方法采用Shim-pack C18色谱柱,流动相A为甲醇,流动相B为含0.025%氨水和0.05mmol·L^-1醋酸铵的水溶液,采用梯度洗脱方式。质谱检测方式：SIM。以瑞舒伐他汀为内标,血浆样品用乙酸乙酯提取浓缩检测,进行LC-MS分析。结果匹伐他汀在0.2～200.0ng·mL^-1内线性关系良好（r=0.9999）;平均提取回收率均为86.28%;日内日间RSD均小于12%。结论本方法快速、简捷、准确,适用于匹伐他汀的临床药动学研究和血药浓度监测。

Determination of the Concentration of Pitavastatin in Human Plasma by LC-MS and Subsequent Application to a Clinical Study

OBJECTIVE To establish an LC-MS method for the determination of pitavastatin in the human plasma.METHODS Pitavastatin and internal standard（IS,rosuvastatin） were separated on a Shim-pack C18 column.The mobile phase consisted of methanol/water（A/B） with 0.025% aqueous ammonia and 0.05 mmol·L^-1 ammonium acetate.Gradient elution mode was established.The samples were extracted with ethyl acetate and determined by LC-MS with selected ion monitoring（SIM） mode.RESULTS The linear calibration curve was obtained in the concentration range of 0.2-200.0 ng·mL^-1（r=0.999 9）,the average extraction recovery was 86.28% and the RSD of inter-and intra-day were less than 12%.CONCLUSION The developed analytical method was proved accurate,rapid,convenient,and suitable for the determination of pitavastatin in the human plasma and pharmacokinetic studies of pitavastatin.