Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC AREA UNDER CURVE METHOD FOR QUANTITATIVE ESTIMATION OF RANOLAZINE IN API AND TABLET FORMULATION

Jayprakash B. Ugale* and Sugandha V. Mulgund

Abstract

The aim of present work was to develop an accurate, precise, reproducible and economical UV spectrophotometric Area Under Curve method for estimation of Ranolazine. This Area Under Curve method of UV spectrum between 261 to 281 nm was validated as per ICH guideline Q2 (R1). The method has followed linearity in the range of 75-200 μg/ml. The value of correlation coefficient was 0.998. Satisfactory values of Percent relative standard deviation for the intraday and inter-day precision studies indicated that method is precise. Results of the recovery studies (99.42% to 99.97%) showed accuracy of the method. LOD and LOQ were calculated as 10.77 μg/ml and 32.63 μg/ml, respectively. The developed method can be used for routine estimation of Ranolazine in bulk and tablet formulation.

Keywords: Area Under Curve, Ranolazine, UV spectrophotometry, Quantitative estimation.