Abstract

COMPARATIVE QUALITY CONTROL TESTS OF VARIOUS COMMERCIAL BRANDS OF CETIRIZINE HYDROCHLORIDE TABLETS AS PER INDIAN PHARMACOPOEIA

Somi Borah*, Dr. Partha Jyoti Gogoi, Lipika Baro and Manaswini Bharadwaj

ABSTRACT

The main objective of this study was to evaluate the various quality control tests of Cetirizine Hydrochloride 10mg tablets available in market and their compliance with the acceptance limits according to Indian Pharmacopoeia. For this research work three different brands of Cetirizine Hydrochloride 10mg tablets were purchased and analysed for all the pharmacopoeial tests. The test for identification, assay and uniformity of content were carried out by High Performance Liquid Chromatography using (Agilent 1100series) equipped with an UV detector and stainless steel column (25cm × 4.6mm × 5μm) packed with octadecylsilane chemically bonded to porous silica. The dissolution test was carried out in USP Type II Apparatus (Paddle) /Apparatus 1 of I.P. The dissolution medium used was 900ml of 0.1M Hydrochloric acid with the speed, temperature and time of apparatus set at 100rpm, 37±0.5°C and 45 minutes respectively. An UV-Vis Spectrophotometer (Cary 100, Varian) was used to calculate the percentage release of Cetirizine Hydrochloride tablets at wavelength 230nm. The research work indicated that the three different brands did not show much difference in their results and they were found to be within the acceptance limits. The study was conducted to evaluate the different brands of Cetirizine Hydrochloride 10mg tablets of various pharmaceutical companies that whether they qualify all the test mentioned in I.P. thereby suggesting their quality and efficacy for use among the general public.

Keywords: Cetirizine Hydrochloride, Quality control, Pharmacopoeia, Assay, Content Uniformity, Dissolution.