Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF RANITIDINE AND ONDANSETRON IN PHARMACEUTICAL FORMULATIONS

Vaibhav R. Mandale*, Subhash S. Palekar, Monali V. Patel, Niyati A. Borkar, Avinash R. Tekade, Archana M. Karnik

Abstract

A new simple isocratic analytical method has been developed and validated for estimation of Ranitidine and Ondansetron simultaneously by RP-HPLC in bulk and pharmaceutical combined dosage form. The separation was carried out by using Agilent CN 250 mm X 4.6 mm 5 μm column with mobile phase containing the mixture of Acetonitrile: Buffer in ratio of 55: 45% v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min and UV detection was found at 225 nm. The selected chromatographic conditions were found to separate Ranitidine (Rt = 2.514 min) and Ondansetron (Rt =6.354 min) having a good resolution. Linearity of Ranitidine and Ondansetron was found to be 50 – 200 μg/ml and 8 - 32 μg/ml respectively with correlation coefficient of 0.999 & 0.999 respectively. The developed method was validated as per ICH guidelines. The amounts of both the drugs were found to be in good agreement with label claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. Hence, this method is used for routine analysis of titled drugs in combination of injection formulation.

Keywords: Ranitidine, Ondansetron, RP-HPLC, Validation.