DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HPLC METHOD FOR ESTIMATION OF ONDANSETRON HYDROCHLORIDE IN BULK DRUG

Abstract

A simple, accurate rapid and precise RP-HPLC method has been developed and validated for determination of Ondansetron hydrochloride in bulk drug. The RP-HPLC separation was achieved on hypersil C18 column (216 mm, 4.6 mm, 5µm) using mobile phase methanol: acetonitrile (50:50 v/v) at flow rate of 1.2 ml/min at ambient temperature. The retention times were 2.6 min. for Ondansetron hydrochloride.Calibration plots were linear over the concentration range 10-50µg/ml. Quantification was achieved with photodiode array detection at 216 nm over the concentration range of 10-50 µg/ml. The method was validated statistically and applied successfully for the determination of Ondansetron hydrocloride. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of Ondansetron hydrochloride in bulk drug.