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Application of High Performance Liquid Chromatographic Technique for Olopatadine Hydrochloride and its Impurity in Ophthalmic Solution

R. V. Rele and C. B. Warkar

The present work describes the ion pair RP-HPLC method for determination of olopatadine hydrochloride and its related substances. The separation of olopatadine hydrochloride and impurities were achieved on Kromasil 100 C18 (150 x 4.6 mm i.d.), 3.5 μ column. The mobile phase consisted of buffer and acetonitrile (80 : 20 v/v). The flow rate was maintained at 1.5 mL/min with a detection wavelength at 220 nm and the column temperature was maintained at 25°C. The method was validated for performance characteristics like specificity, response factor, limit of detection and quantita tion, linearity, accuracy, precision, robustness and stability of sample solution. The detection limit for e-isomer and olopatadine hydrochloride was found to be 0.0891 μg/mL and 0. 08924 μg/mL respectively. The quantitation limit was found to be 0.2701 μg/mL and 0.2704 μg/ml respectively. The linear range for olopatadine hydrochloride was found to be 0.27 – 7.5 μg/mL whereas for e-isomer it was found to be 0.27 – 3.75 μg/mL. The method has been successfully adopted for determining the quality of olopatadine hydrochloride ophthalmic solution with good recoveries of the impurities at trace levels.