Development and validation of RP-HPLC method for the estimation of Ramosetron hydrochloride in tablet dosage form

Abstract

A  simple, rapid, sensitive, accurate and precise RP-HPLC method has been developed and validated for the estimation of Ramosetron hydrochloride in bulk and tablet dosage form. The method was carried out using Hypersil ODS C18 (150 x 4.6mm I.D., 5 m particle size) column and mobile phase comprised of buffer pH 3.2 and acetonitrile in proportion of ratio of 50:50 v/v and degassed in ultrasonic water bath. The flow rate was 0.8 mL/min and the detection wavelength was at 310 nm. The linearity was observed in the range of 1-5 µg/mL with a correlation coefficient of 0.999. The retention time of Ramosetron hydrochloride was 2.54 min. The method was validated as per ICH guidelines for its linearity, precision, accuracy, specificity, limit of detection, limit of quantitation, and by performing recovery studies. The percentage recovery of the drug Ramostron hydrochloride was 99.76 % to 100.33 %. for the tablet formulation. The proposed method is suitable for the routine quality control analysis for the estimation of Ramosetron hydrochloride in bulk and tablet dosage form.