Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF LEVOSULPIRIDE IN BULK AND TABLET DOSAGE FORM

*Dattaprasad D. Musle and Ashish A. Chavan

ABSTRACT

A simple, reliable, precise, and cost-effective spectrophotometric method for estimating Levosulpiride in bulk and marketed formulations has been developed. Levosulpiride was measured using a UV-Visible double beam spectrophotometer at 291.2 nm in pH 6.8 phosphate buffer. Linearity was observed in the established method over the concentration range of 10-100g/ml of Levosulpiride and was found to be in accordance with Beer's law. The linear regression coefficient was found to be 0.999. The study findings have been statistically tested, and recovery tests have verified the accuracy of the proposed procedure. The method's precision (intra-day and inter-day) was found to be within limits (RSD 2%). The method's sensitivity was determined by determining the limit of detection and limit of quantification. The percentage of levosulpiride in the advertised formulation (LEFIT-50) was found to be 99.46%. Based on the findings of this study, it is possible to conclude that the method for estimating Levosulpiride in pure form and pharmaceutical dosage form is quick, rapid, reliable, precise, and cost-effective, and that it can be used successfully in the quality control of pharmaceutical formulations and other routine laboratory analyses.

Keywords: levosulpiride, UV spectrophotometer, beer’s law, validation.