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目的:建立测定人血浆中盐酸乙哌立松的高效液相色谱-电喷雾质谱联用(HPLC/ESI-MS)方法。方法:血浆经碱化后,叔丁基甲醚提取,HPLC/ESI-MS选择离子检测。结果:本法线性范围为32~0.25μg·L~(-1),最低检测浓度为0.0μg·L~(-1)(S/N≥3)。血浆中乙哌立松的回收率为99.10~99.85%,日内RSD≤5.9%,日间RSD≥10.8%。结论:本法适用于盐酸乙哌立松的生物等效性研究和血药浓度监测。
Objective: To establish a high performance liquid chromatography-electrospray ionization mass spectrometry (HPLC / ESI-MS) method for the determination of Eperisone Hydrochloride in human plasma. Methods: The plasma was alkalified, extracted with tert-butyl methyl ether, and selected by HPLC / ESI-MS. Results: The linear range of this method was 32 ~ 0.25μg · L -1, the lowest detection concentration was 0.0μg · L -1 (S / N≥3). The recovery rate of Eperisone in plasma was 99.10% -99.85%, RSD≤5.9%, daytime RSD≥10.8%. Conclusion: This method is suitable for bioequivalence study of eperisone hydrochloride and plasma concentration monitoring.