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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 a method for the determination of pitavastatin in plasma by high performance liquid chromatography. METHODS: The analytical column was Shimadzu VP-ODS (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-30 mmol·L -1 potassium dihydrogen phosphate buffered saline-triethylamine (acetic acid adjusted to pH = 4.0) 57: 0.1), the flow rate of 1.0mL.min-1, detection wavelength of 244nm. Results: Pitavastatin showed a good linearity (r = 0.9998) within the range of 0.832 ~ 106.5μg.L-1, the lowest limit of quantification was 0.832μg.L-1. High, medium and low concentrations of three kinds of day and day RSD <8%. Conclusion: The method is simple, sensitive and accurate and is suitable for monitoring the plasma concentration of pitavastatin and its pharmacokinetics.