A simple and sensitive LC-MS/MS method for quantification of Bepridil in rat plasma and its application to pharmacokinetic studies

Publication date: Available online 18 April 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Bhavesh D. Patel, Nageswararao P, Rajesh Alamanda, Ajit R. Gadekar, Amol A. Raje, Rakshit AmetaAbstractBepridil is potent inhibitor of Na+, K+ and Ca+ channel in cardiomyocytes. It has demonstrated strong antianginal effect with type I antiarrhythmic and with minimum antihypertensive therapeutic effect. Till date, a specific LC-MS/MS method to quantify Bepridil concentrations in biological matrix have not been reported yet.. In current study, a highly sensitive, specific and simple LC-MS/MS method for quantification of antianginal drug Bepridil in rat plasma is presented. The LC-MS/MS method was validated in terms of selectivity, specificity, sensitivity, accuracy and precision, matrix effect, extraction recovery and stability as per USFDA’s bioanalytical method validation guideline. The validated assay was applied for quantification of Bepridil from pharmacokinetic study in rats following oral and intravenous administration. The lower limit of quantification (LLOQ) of Bepridil was 1 ng/mL. The calibration curve ranges from 1 ng/mL to 1000 ng/mL with desirable linearity and r2> 0.99. The method exhibited 10-fold dilution integrity. The intra-day and inter-day accuracy were within 101.32 - 96.80% and 102.87 - 95.35% with coefficient of variation 10.11 - 2.89% and 10.45 - 3.97% respectively. No significant interference observed by endogenous peak at the re...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research