Department of Pharmacology, Madras Medical College, Chennai, Tamilnadu, India.

Department of Pharmacology, Madras Medical College, Chennai, Tamilnadu, India.

Department of Pharmacology, Madras Medical College, Chennai, Tamilnadu, India.

Department of Pharmacology, Madras Medical College, Chennai, Tamilnadu, India.
Bioequivalence ,Bioavailability ,Trandolapril/Verapamil hydrochloride ,

The purpose of this study was to compare the pharmacokinetic parameters of Trandolapril/Verapamil hydrochloride Extended Release Film Tablets 4/240 mg of one company with that of the reference product Trandolapril/Verapamil hydrochloride Extended Release Film Tablets 4/240 mg (Tarka®).A validated Liquid Chromatography and Mass Spectroscopy (LC-MS/MS) method was employed for the estimation of Trandolapril and Verapamil in plasma. Pharmacokinetic analysis was done by Non- compartmental method of analysis using the WinNonlin® Version 5.3.The statistical analysis was performed using the SAS® statistical software (version: 9.2). The 90% confidence intervals of the T/R ratio of Lntransformed C max, and AUC0-t, AUC0-∞ were outside the bioequivalence range of 80%-125%. Hence the Test and Reference products of Trandolapril/Verapamil hydrochloride were not bioequivalent. From this study we can conclude that, the combination of Trandolapril/Verapamil hydrochloride (Test) Extended Release Film Tablets 4/240 mg is not bioequivalent to reference Trandolapril/Verapamil hydrochloride (Tarka®).

5 , 3 , 2015