Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF AGOMELATINE IN BULK AND TABLET DOSAGE FORM

A. Srinivas* G. Sai and K. Sridhar Reddy

Abstract

Development an accurate, simple, precise and rapid method for the estimation of Agomelatine in bulk and Tablet dosage form. The method uses Reverse phase High performance Liquid Chromatography (RP-HPLC). PHENOMENEX Luna C18, (5μm, 250 x 4.6mm) column operated with a mixture of mixed phosphate buffer of pH 6 with ortho phosphoric acid and Acetonitrile(55:45) as mobile phase was found to be suitable for the estimation. The flow rate was maintained at 1ml/min. Detection was carried out at 230nm using a UV detector. The total run time was less than 10min the retention time of 2.7min for Agomelatine. Validation of the method was performed for precision, accuracy, linearty, ruggedness, specificity and sensitivity to confirm to the ICH guidelines for validation of an analytical method.

Keywords: Agomelatine, RP-HPLC, Method development, Validation.