Method Development and Validation for the Simultaneous Analysis of Duloxetine HCL and Methylcobalamine by RP-HPLC

Abstract

A simple, accurate and precise method for simultaneous estimation of Methylcobalamin and Duloxetine by RP-HPLC method has been developed. The chromatographic conditions were successfully developed by using inertsil ODS C18 5��m (4.6*250mm) column, the flow rate was 1ml/min, the mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (30:70%v/v) (pH was adjusted with orthophosphoric acid), detection wave length was 255nm. The retention times were found to be 3.594 min and 5.328 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). T h e suggested RP-HPLC method can be used for routine analysis of Methylcobalamin and Duloxetine in API and Pharmaceutical dosage form.