DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FAMOTIDINE IN SUSPENSIONS

Abstract

The reference pharmacopeias provide HPLC methods for determination of Famotidine a potent H2- receptor antagonist in Pharmaceutical preparations, which are costly and unaffordable for most pharmaceutical laboratories and research students. Keeping in view the socio-economic conditions of our country there is a need to develop an alternate technique, so that the research studies become easier and cheaper. The present study is on the development and validation studies of a UV spectrophotometric method for the quantitative determination of Famotidine as active and in formulation i.e Suspensions. The method includes extraction of an aqueous layer using organic solvent Diethyl ether and measurement of absorbance at 265 nm. Different aspects of validation were taken into consideration such as Accuracy, Precision, Linearity, Specificity, Limit of detection and Limit of quantification. The method is found to be specific with no interference of excepients and is suitable over a range of 10-50µg /mL of Famotidine. The mean % recovery was found to be 99.32%-100.17 % (n=6). The intra and inter day RSDs (n=6) were 0.45%-0.57%. The method is accurate, cost effective and fast.