摘要
建立了LC-MS/MS法测定人血浆中克拉霉素的浓度,并研究了10名健康受试者口服国产克拉霉素片及其缓释片的药物动力学。以盐酸舍曲林为内标,乙腈-0.1%甲酸(70∶30)为流动相,采用AlltimaC18色谱柱,流速为0.2ml/min,血浆样品经乙腈沉淀后测定。质谱仪为串联四极杆质谱,采用大气压化学离子源(APCI),正离子扫描(ESI+);离子选择通道分别为748.6/590.4(克拉霉素)和306.4/275.2(盐酸舍曲林)。克拉霉素在0.02~5μg/ml的范围内线性良好,方法回收率为101.3%~107.8%;日内和日间RSD均小于4.5%。
A LC-MS/MS method was established for determination of clarithromycin in human plasma. Pharmacokinetics of clarithromycin tablets and sustained-release tablets in 10 healthy volunteers were discussed. The analytes were extracted by acetonitrile and sertraline hydrochloride was used as internal standard. An Alltima C18 column was used with the mobile phase of acetonitrile -0.1% formic acid solution (70 : 30), and the flow rate was 0.2ml/min. A tandem mass spectrometer was used as detector equipped with air pressure chemical ionization source, and it was operated in the positive ion mode. Selected ion monitoring ions were 748.6/590.4 for clarithromycin and 306.4/275.2 for sertraline hydrochloride, respectively. The calibration curve of clarithromycin was linear in the range of 0.02 - 5μg/ml. The recovery was 101.3 % - 107.8 %. The RSDs of inter- and intra-day were less than 4.5 %.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2006年第11期761-764,共4页
Chinese Journal of Pharmaceuticals