DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE ESTIMATION OF TIMOLOL MALEATE IN API AND FAST DISSOLVING TABLETS

Gagan Shah*, Varinder Soni, Approva Chawla and R. K. Dhawan

ABSTRACT

A simple, precise and reproducible validation method was develop for Timolol Maleate as per ICH (International Council for Harmonization) guidelines Q2R(1) and subsequently stability indicating method as per ICH guidelines Q1A(R2). Chromatographic evaluation was carried out on C18 column of Agilent (25 cm x 4.6 mm), (i.d. 5 μm.) with a mobile phase consist of Methanol : Water (20:80 v/v). Flow rate was maintained to 0.8ml/min. The stability indicating data revealed that Timolol Maleate was found to be unstable alkaline condition. The validated method was applied various validation parameters like Linearity (calibration curve), Precision, Accuracy, Robustness, LOD and LOQ were found to be 0.9μg/ml and 2μg/ml. The validated method can be used for estimation of Timolol Maleate in prepared Fast Dissolving Tablets (FDTs) by using Croscarmellose Sodium (CCS) as a superdisintegrant a calculated their optical parameters.

Keywords: Timolol Maleate, RP-HPLC, Stability Studies, FDTs.