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| 摘要: |
| 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0.05 mmol·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0.2~200.0 ng·mL-1内线性关系良好(r=0.999 9)；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。 |
| 关键词: 匹伐他汀 液相色谱-质谱联用 血药浓度 |
| DOI： |
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| Determination of the Concentration of Pitavastatin in Human Plasma by LC-MS and Subsequent Application to a Clinical Study |
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WEN Jinhua XIONG Yuqing*
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| Abstract: |
| 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. |
| Key words: pitavastatin LC-MS plasma drug concentration |
