Development and Validation of UV Spectrophotometric Method for Estimation of Agomelatine in Bulk and Pharmaceutical Dosage Form

Abstract

A simple, rapid, accurate, precise, sensitive and economical UV Spectrophotometric method has been developed for estimation of agomelatine from bulk and pharmaceutical formulation. The λmax of agomelatine in water was found to be 233 nm. The parameters linearity, precision, accuracy, robustness were studied according to International Conference on Harmonization guidelines. The drug follows linearity in the concentration range 2-8μg/ml with correlation coefficient value 0.9981. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 50%, 100% and 150 %. The % recovery was found to be in the range 98.94%– 100.05%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. The above method was a cost-effective quality-control tool for routine analysis of agomelatine in bulk and in pharmaceutical dosage form.