Development and validation of a stability indicating RP-HPLC method for determination of metoprolol succinate in pharmaceutical dosage forms

A simple, precise, rapid and accurate reverse phase HPLC method has been developed for the determination of Metoprolol succinate in pharmaceutical dosage form. An isocratic separation of metoprolol was achieved on Inertsil ODS-2, 150mm x 4.6 mm, 5.0 mm or equivalent column was used with Photo Diode Array detector. The mobile phase consisting of Buffer,Methanol, Acetonitrile (600:50:350) at a flow rate of 1.0ml/min at ambient temperature. The quantitation was achieved with UV detection at 223nm. The method was linear over the concentration range of 20-200μg/ml and the correlation coefficient was found to be (r2 =0.999). The retention time of the drug was 11.37min.The method precision for the determination of assay was below 2% RSD, indicated a good precision of the analytical method. The percentage recovery of Metoprolol succinate was found to be 100.26%. Robustness of the method was performed by using different flow rates& temperatures and it was found as robust. The validation of method was done by using ICH Guidelines.

Author(s): CH Naveen Kumar

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