DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF OLOPATADINE HYDROCHLORIDE IN BULK DRUG AND IT'S FORMULATIONS Research Article

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the estimation of Olopatadine hydrochloride, using a Inertsil-ODS 3V column and a mobile phase composed of Buffer: Methanol: Triethylamine (55:45:0.1, %v/v), pH 3.0 adjusted with o-phosphoric acid. The retention time of Olopatadine hydrochloride was found to be 6.3 min. Linearity was established for Olopatadine hydrochloride in the range of 35-65 µg/ml. The percentage recovery of Olopatadine hydrochloride was found to be in the range of 98.70-100.40%. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat and photolytic degradation. The degradation studies indicated Olopatadine hydrochloride showed degradation in acid, alkali and H2O2 while it was found stable in photolytic and in presence of dry heat. The degradation products of Olopatadine hydrochloride in acidic, alkaline and oxidative conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for the quantitative analysis of Olopatadine hydrochloride in bulk drugs and formulations.