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

Author(s): 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.

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