Development of Stability Indicating RP-HPLC Method for Estimation of Clemastine Fumarate and its Pharmaceutical Dosage Form

Abstract

A simple, fast and precise stability indicating RP-HPLC method was developed for quantification of Clemastine Fumarate in pure and pharmaceutical dosage form. The quantification was carried out using LiChrospher® 100 RP-C8 endcapped column (5μm, 150 × 4.6mm) and mobile phase comprised of methanol and water (0.05% triethyamine) in proportion of ratio 90: 10 and degassed under ultrasonication. The flow rate was 0.8ml/min and effluent was monitored at 220nm. The retention time of Clemastine Fumarate was found to be 7.49±0.039 min and peak was separated. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guideline. Linearity of Clemastine Fumarate was in the range 15–50μg/mL. The percentage recovery of Clemastine Fumarate were 98.46 to 99.99% from tablet formulation. The stability-indicating capability was established by forced degradation experiments. The proposed method suitable for determination of Clemastine Fumarate in pharmaceutical dosage form.