液相色谱-串联质谱法测定人血浆中瑞舒伐他汀钙浓度及临床药代动力学研究

Determination of rosuvastatin calcium in human plasma by LC-MS/MS and its clinical pharmacokinetics in Chinese healthy volunteers

目的：建立测定人血浆中瑞舒伐他汀钙的液相色谱．串联质谱法，考察瑞舒伐他汀钙在中国健康志愿者体内的药代动力学。方法：含有瑞舒伐他汀钙和氟伐他汀钠的血浆样品经液-液提取后，进行色谱分析，在三重四极杆串联质谱仪上，以多反应离子监测方式进行定量分析。结果：瑞舒伐他汀钙的定量下限为0．03ng／mL，线形范围为0．03～60ng／mL，精密度与准确度符合生物样品分析要求。结论：该方法操作简便、快速、灵敏度高，适合瑞舒伐他汀钙的临床药代动力学研究。

AIM： To establish a rapid and sensitive LC-MS/MS method for the analysis of rosuvastatin calcium in plasma and study the pharmacokinetics of rosuvastatin on China healthy volunteers. METHODS： Plasma samples containing rosuvastatin calcium and fluvastatin sodium were extracted with liquid-liquid extraction, followed by liquid chromatographic separation and on-line MS/MS using turboionspray ionization as an interface detection by the muhi-reaction monitoring. RESULTS： The limit of quantitation of method for rosuvastatin calcium was 0.03 ng/mL, the calibration curves in plasma were linear over the range of 0.03 to 60 ng/mL and within-batch and between-batch variation over the range were less than 10%. CONCLUSION： The method is shown to be accurate and convenient, and suitable for pharmacokinetic studies of rosuvastatin calcium.