Abstract: Journal of Material Sciences & Applied Engineering

Abstract:
This study aimed to evaluate the bioequivalence of two benidipine formulations by analyzing the pharmacoki netics of individual benidipine isomers ((−)-alpha benidipine and (+)-alpha benidipine) in healthy male human volunteers under fed conditions. Plasma concentrations of benidipine isomers were quantified using a specific and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) validated method. Acquisition was performed in multiple reaction monitoring (MRM) mode, by monitoring the transitions: m/z 506.3>174.2 for (−)-alpha benidipine and (+)-alpha benidipine and m/z 511.2>179.2 for (+)-alpha benidipine d5 and (−)-al pha benidipine d5 511.2>179.3 as IS. The method was validated over the concentration range of 30–10000 ng/ ml for (−)-alpha benidipine and 50–10000 ng/ml for (+)-alpha benidipine in human plasma. Based on the con ducted bioequivalence study, it was concluded that the benidipine hydrochloride test and reference formulations are bioequivalent under fed conditions