DISSOLUTION PROFILE STUDIES OF BCS CLASS II DRUG VALSARTAN BY BIOWAIVER PROCEDURE

Abstract

Drug release studies (or in vitro release) of valsartan in three dissolution media simulating the main sections of the gastrointestinal tract were conducted. The concentrations were determined using UV/Vis spectrophotometer (Varian Cary 50) at 254 nm. The study was conducted using dissolution apparatus with the paddle assemble; 5-mL sample aliquots were withdrawn at 5, 10, 15, and 30 min. Estimation f2 parameter confirmed the equivalence of valsartan dissolution kinetics: f2=67 in hydrochloric acid solution, pH 1,2; f2=57 in phosphate buffer, pH 4,5, and in phosphate buffer, pH 6,8 - dissolution amount is greater than 85% at 15 min, so the two products are deemed equivalent, and a profile comparison is not necessary.

Keywords

• comparative dissolution profile
• biowaiver
• valsartan