STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF CEPHALEXIN AND BROMHEXINE IN PHARMACEUTICAL DOSAGE FORM
Keywords:Cephalexin, Bromhexine, RP-HPLC, Validation.
A simple, precise and rapid RP-HPLC method has been developed and validated for the simultaneous determination of Cephalexin and Bromhexine in pharmaceutical dosage form. The method was carried out using Kromasil C8 column (250 mm x 4.6 mm, 5µm) and mobile phase comprised 0.1% Ortho Phosphoric Acid (OPA) and acetonitrile in the ratio of 45:55 v/v and degassed under ultrasonication. The flow rate was 1.0 mL/min and the effluent was monitored at 215 nm. The retention times of Cephalexin and Bromhexine were 2.29 min and 2.81 min respectively. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation. Linearity was in the range of 62.5 to 375 µg/mL for Cephalexin and 1 to 6 µg/mL for Bromhexine respectively. The percentage recoveries of both the drugs were ranging from 98.27 to 100.02% for Cephalexin and 98.17 to 99.32% for Bromhexine respectively from the tablet formulation. The proposed method is suitable for the routine quality control analysis of simultaneous determination of Cephalexin and Bromhexine in bulk and pharmaceutical dosage form.