Liu Ping, Liang Sun, Wang Ben-Jie, Guo Rui-Chen
Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China.
Eur J Drug Metab Pharmacokinet. 2009 Jul-Sep;34(3-4):177-84. doi: 10.1007/BF03191171.
We developed and validated a sensitive and low sample volume liquid chromatographic-mass spectrometric (LC-MS) method for determination of Promethazine hydrochloride in human plasma (0.5 ml) or urine (0.1 ml). The lower limit of quantification in human plasma and urine was 1.00 ng/ml. The inter- and intra-day precisions (CV %) in both plasma and urine were lower than 10%, the mean method accuracies and recoveries from spiked plasma samples at three concentrations were more than 97%. The developed method was successfully applied to determine Promethazine hydrochloride in human plasma and urine, and proved suitable to clinical pharmacokinetic study.
我们开发并验证了一种灵敏且所需样本量少的液相色谱-质谱（LC-MS）方法，用于测定人血浆（0.5 ml）或尿液（0.1 ml）中的盐酸异丙嗪。人血浆和尿液中的定量下限为1.00 ng/ml。血浆和尿液中的日间和日内精密度（CV%）均低于10%，三种浓度加标血浆样本的方法平均准确度和回收率均超过97%。所开发的方法成功应用于测定人血浆和尿液中的盐酸异丙嗪，并证明适用于临床药代动力学研究。
