Analytical method development and validation for the simultaneous estimation of Metoprolol and Benidipine by RP-HPLC in bulk and tablet dosage forms

Abstract

Objective: The day by day new combinations drugs are being introduced in market. Then the multiple therapeutic agents which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combination. An  accurate,  precise  and  reproducible  RP-HPLC  method  was developed for the simultaneous quantitative determination of METO and BENI in tablet dosage forms. Methods: Younglin (S. K.) gradient system UV detector and C18 column with 250 mm x 4.6 mm i. d.  and 5μm particle size Acetonitrile: OPA water (45: 55v/v) pH 2.5 was used as the mobile phase for the method. The detection wavelength was 230 nm and flow rate was 1ml/min. Results: In the developed method, the retention time of Metoprolol and Benidipine were found to be 2.9833 min and 7.3833 min. The developed method was validated according to the ICH guidelines. Conclusion: The developed method was validated according to the ICH guidelines. In this methods linearity, precision, range, robustness was within the limits as specified by the ICH guidelines.