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目的:建立定量测定人体血浆中阿托伐他汀浓度的HPLC-MS/MS的方法。方法:以吲哚美辛为内标,采用Shim-pack VP-ODS柱(150×2.0 mm I.D.,5μm,日本Shimadzu Technologies Inc.公司)为固定相;乙腈-0.5%甲酸溶液(90:10,v/v)为流动相,流速为0.3 ml/min;通过电喷雾离子源(ESI),以正离子多反应监测模式进行检测。阿托伐他汀与内标用于检测的离子对分别为m/z 559.4 m/z 250.3和m/z 358.3 m/z 139.2。结果:阿托伐他汀在0.10~20.00 ng/ml范围内与峰面积比值线性范围良好(r=0.9962),定量下限为0.10 ng/ml,日内日间精密度的RSD均小于12%,平均回收率大于71%。结论:所建方法准确度高,方法灵敏,专属性强且操作简便,可适用于阿托伐他汀的血药浓度测定和临床药代动力学研究。
Objective: To establish a method for the quantitative determination of atorvastatin in human plasma by HPLC-MS / MS. Methods: Indomethacin was used as an internal standard and a Shim-pack VP-ODS column (150 × 2.0 mm ID, 5 μm, Shimadzu Technologies Inc., Japan) was used as the stationary phase; acetonitrile- v / v) as mobile phase at a flow rate of 0.3 ml / min. The electrospray ionization source (ESI) was used for detection in positive ion multiple reaction monitoring mode. The ion pairs used for the detection of atorvastatin and the internal standard were m / z 559.4 m / z 250.3 and m / z 358.3 m / z 139.2, respectively. Results: Atorvastatin had a good linearity (r = 0.9962) in the range of 0.10-20.00 ng / ml and a lower limit of quantification of 0.10 ng / ml. The RSDs of intra-day and inter-day precision were less than 12% Rate greater than 71%. Conclusion: The proposed method is accurate, sensitive, specific and easy to operate. It can be applied to the determination of blood concentration and clinical pharmacokinetics of atorvastatin.