Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RANITIDINE AND ONDANSETRON IN BULK AND PHARMACUTICAL FORMULATION

Vaibhav R. Mandale*, Dr. Subhash S. Palekar, Dr. Prakash T. Sangale, Dr. Tauqueer Kadu, Dr. Atul S. Sayare, Archana M. Karnik.

Abstract

An accurate, specific and precise UV spectrophotometric method was developed for the simultaneous determination of Ranitidine (RAN) and Ondansetron (OND) in injection dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λmax) was found to be 230 nm for RAN and 216 nm for OND. The linearity of the proposed method was found in the range of 50-200 μg/ml and 8-32 μg/ml for RAN and OND respectively. Calibration curves showed a linear relationship between the absorbance and concentration. The line equation for RAN Y = 0.0222X - 0.0226 with r2 of 0.9999 and for OND Y = 0.0292X - 0.0149 with r2 of 0.9998 was obtained. Validation was performed as per ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The LOD was found to be 0.0454 and 0.656 μg/ml for RAN and OND and the LOQ was found to be 0.151 and 2.18 μg/ml for RAN and OND respectively. The proposed method was simple, sensitive, precise, accurate, quick and useful for routine analysis of RAN and OND in injection formulations.

Keywords: Simultaneous equation method, Validation, Ranitidine, Ondansetron, UV spectrophotometry.