Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF BRIMONIDINE TARTRATE AND TIMOLOL MALEATE USING RP-HPLC METHOD IN BOTH BULK AND PHARMACEUTICAL DOSAGE FORM

Jomol Joseph*, N. J. R. Hepsebah and K. Deepthi

ABSTRACT

A simple and effective RP-HPLC method had been developed for the estimation of Brimonidine Tartrate and Timolol Maleate in Ophthalmic dosage form, using Inertsil ODS C18 (250 x 4.6 mm, 5m.), mobile phase Phosphate Buffer and Acetonitrile (68:32), detection wavelength at 320 nm, at flow rate of 0.8 ml/min at retention time 2.85 min for Brimonidine Tartrate, 3.68 min for Timolol Maleate. Linearity was obtained in the range of 25 µg/ml to 150 µg/ml for Brimonidine Tartrate and 62.5 µg/ml to 375 µg/ml for Timolol Maleate, respectively. The correlation coefficient was found to be 0.999 for both the drugs. The Recovery studies were performed for Brimonidine Tartrate and Timolol in the range of 50% - 150 %. The % Assay for Brimonidine Tartrate is 99.85 % and Timolol Maleate is 99.77 %. Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence, the method could be successfully applied for routine analysis of Brimonidine Tartrate and Timolol Maleate in combined ophthalmic dosage form.

Keywords: Brimonidine Tartrate and Timolol Maleate, RP-HPLC, ICH.