" Method Development and Validation for the Simultaneous Analysis of Duloxetine Hcl and Methyl Cobalamine By Rphplc

A simple, accurate and precise method for simultaneous estimation of Methyl-cobalamin and Duloxetine by RP-HPLC method has been developed. The chromatographic conditions were successfully developed by using inertsil ODS C18 5µm (4.6X250mm) 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 suggested RP-HPLC method can be used for routine analysis of Methyl-cobalamin and Duloxetine in API and Pharmaceutical dosage form. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)).