Development and Validation of Spectrophotometric Method for Estimation of Levosulpiride in Bulk and Tablet Dosage Form

Abstract

A simple, accurate, precise and economical spectrophotometric method has been
developed for estimation of Levosulpiride in bulk form as well as marketed formulations.
The estimation of Levosulpiride was done at 291.2 nm in pH 6.8 phosphate buffer using
UV-Visible double beam spectrophotometer. In the developed method, linearity over the
concentration range of 10-100µg/ml of Levosulpiride was observed and was found in
agreement of Beer’s law. The linear regression was found to be 0.999. The results of analysis
have been validated statistically and recovery studies confirmed the accuracy of the
proposed method. The precision (intra-day & inter-day) of method was found within limits
(RSD < 2%). The sensitivity of the method was assessed by determining limit of detection
and limit of quantification. The percentage of Levosulpiride in the marketed formulation
(LEFIT-50) was observed to be 99.46%. It could be concluded from the results obtained in
the present investigation that the method for estimation of Levosulpiride in pure form and
in pharmaceutical dosage form is simple, rapid, accurate, precise and economical and can
be used, successfully, in the quality control of pharmaceutical formulations and other
routine laboratory analysis.