DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF ONDANSETRON HYDROCHLORIDE IN BULK AND FORMULATION

Abstract

Ondansetron is used as selective 5-HT3 receptor antagonist. In present study, a simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of ondansetron hydrochloride from bulk and pharmaceutical formulation. The developed method was statistically validated in accordance with ICH requirement on the basis of various parameters like linearity, accuracy, precision, sensitivity, repeatability and ruggedness. The drug follows linearity in the concentration range 4-20 ?g/ml with a correlation coefficient value of 0.999 at ?max of 284 nm. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 80%, 100%, and 120%. The % recovery was found to be in the range of 101.08- 101.54%. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise, reproducible and accurate. Ruggedness of the proposed method was also studied with the help of two analysts. The proposed method was then successfully applied to pharmaceutical formulation. Amount of drug estimated was found to be 98-102%, which was in good agreement with the label claim. Excipients used in tablet formulation did not interfere in the estimation of ondansetron by developed method. The proposed method can be successfully employed in the routine analysis of drug in pharmaceutical dosage forms.