Development and validation of a sensitive LC-MS method for the determination of promethazine hydrochloride in human plasma and urine.
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.
Liu
Ping
P
Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China.
Liang
Sun
S
Wang
Ben-Jie
BJ
Guo
Rui-Chen
RC
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D011398:Promethazine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D014147:Tramadol / Q000008:administration & dosage / Q000493:pharmacokinetics
D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D014147:Tramadol; D011398:Promethazine