Abstract

COMPARITIVE EVALUATION OF DISSOLUTION PROFILES OF AMLODIPINEBESYLATE AND HYDROCHLOROTHIAZIDE FIXED DOSE COMBINATION MARKET SAMPLES AS PER QUALITY BY DESIGN GUIDELINES OF USFDA

Naga Harini. Kasu*, Dr. M.Prasada Rao, Doredla. Narasimha rao, Mannempalli.Chandana, Rayudu. Lakshmi prasanna

ABSTRACT

The aim of the present work was to comparatively evaluate three brands of Amlodipine besylate and Hydrochlorothiazide fixed dose combination tablets and determine which brands may be equivalent to each other based on invitro dissolution testing. A method was developed for the estimation of Amlodipine Hydrochlorothiazide in tablets which is simple, quick, reliable, inexpensive and simple. Sampling wavelengths based upon the direct UV spectroscopic data. There was no interference from tablet excipients was observed in this method. The results indicate that the described method can be used for quantitative analysis of the compounds in formulation. Comparative dissolution profile testing was carried out for fixed dose combination market samples as per quality by design guidelines of USFDA in pH 1.2, pH 4.5 and pH 6.8 buffers and in water at different dissolution rpm’s 25,50,75,100, with different dissolution apparatus like basket and paddle and in different dissolution volumes like 500ml,1000ml. . Similarity factor f2 was used for comparing the dissolution profiles. From this work it was determined that brand 1 and 2 were found to be bioequivalent to each other while brand 3 was not equivalent to other two brands.

Keywords: QbD, Amlodipine besylate, Hydrochlorothiazide,UV-Visible spectrophotometer, ICH guidelines, USFDA.