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目的建立液质联用(LC-MS)直接沉淀法测定人血浆匹伐他汀的浓度。方法 Waters Cosmosil Packed Coulmn C18-MS-Ⅱ(2.0mm×150mm,5μm)色谱柱,流动相为10mmol·L-1甲酸胺(含0.1%甲酸)-乙腈(40∶60),流速为0.3mL·min-1,进样体积为20μL,柱温为40℃,样品室温度为15℃,采用内标定量法,内标为罗素伐他汀。结果匹伐他汀线性范围为0.5~1000 ng·mL-1,最低检测限为0.1ng·mL-1,方法灵敏、稳定、特异性高,并已成功地应用到人血浆匹伐他汀药动学研究。结论该方法简便、准确、重复性好,可以准确地定量人血浆匹伐他汀的浓度,适于药理科研。
Objective To establish a liquid chromatography-mass spectrometry (LC-MS) direct precipitation method for the determination of human plasma pitavastatin concentration. Methods The mobile phase consisted of 10 mmol·L-1 formamide (containing 0.1% formic acid) -acetonitrile (40:60) with a flow rate of 0.3 mL · mL at a mobile phase of Waters Cosmosil Packed Coulmn C18-MS- min-1, the injection volume was 20μL, the column temperature was 40 ℃, the temperature of the sample compartment was 15 ℃, and the internal standard method was used. The internal standard was Rusatin. Results The linear range of pitavastatin was 0.5-1000 ng · mL-1 with the lowest detection limit of 0.1 ng · mL-1. The method was sensitive, stable and specific and has been successfully applied to the pharmacokinetics of human plasma pitavastatin the study. Conclusion The method is simple, accurate and reproducible. It can accurately determine the concentration of pitavastatin in human plasma and is suitable for pharmacological research.