Abstract

STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF LACOSAMIDE IN BULK AND TABLET DOSAGE FORM

Gunjan Kalyani*, Baikuntha Adjuad

Abstract

To develop a simple, precise, accurate, less time consuming & economical first order derivative spectroscopic method. Development of SIAM using developed first order derivative method. Distilled water was selected as a solvent for estimation of Lacosamide with the absorption at 250 nm. The linearity was established over the concentration range of 5-25 μg/ml. The correlation coefficient (r2) for Lacosamide was found to be 1. The mean % recovery was found to be 100% for Lacosamide. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed method is recommended for routine analysis since it is rapid, simple, accurate, sensitive and specific.

Keywords: Lacosamide, Spectrophotometry, First order derivative, Validation.