Abstract

SIMPLE VALIDATED SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF NEBIVOLOL AND VALSARTAN WITH POSSIBLE DEGRADANTS IN FIXED DOSE PHARMACEUTICAL FORMULATION

D. Prashanthi*, Dr. B. Ramesh and Manish Majumder

ABSTRACT

A novel, simple, accurate, sensitive, economical and stability indicating spectroscopic method has been developed and validated according to ICH Q2R1 guidelines for the simultaneous estimation of Nebivolol and Valsartan in fixed dose pharmaceutical formulations. Pure drug samples were dissolved in 0.1% OPA and Methanol in the ratio of 90:10 and found to have absorbance maxima at 281 nm and 205 nm for Nebivolol and Valsartan respectively. Beer’s law was obeyed over concentration ranges of 1-5 μg/ml for Nebivolol and 16-48 μg/ml for VAL in this method. The correlation coefficient (r2) was found to be 0.999 for both Nebivolol and Valsartan. The % recoveries obtained were 99.8 % – 100.43 % for Nebivolol and 100.01 % – 101.67 % for Valsartan. The % RSD found 0.44 for intraday and 0.17 for interday for Nebivolol and 0.5 for intraday and 0.1 for interday for Valsartan. The limit of detection and limit of quantitation for Nebivolol were found to be 16.5 μg/ml and 50.1 μg/ml respectively and the limit of detection and limit of quantitation for VAL were found to be 6.105μg/ml and 18.5μg/ml respectively. Simultaneous calibration of both drugs in 0.1% OPA and Methanol shows that λmax of one drug does not interfere on the λmax of other drug. Recovery study was performed to confirm the accuracy of the method. The results of analysis have been validated statistically by recovery studies as per ICH guidelines. The method showed good reproducibility and recovery with % RSD <2. Drug was subjected to forced degradation via acid and alkali hydrolysis, oxidation, thermolysis and photolysis. Hence, this proposed method was found to be rapid, specific, precise, accurate and can be successfully applied for the routine analysis of Nebivolol and Valsartan in fixed dose pharmaceutical formulations.

Keywords: UV Spectroscopic method, Validation, Beer’s law, Nebivolol, Valsartan.