Development and validation of analytical methods for olmesartan medoximil and metoprolol succinate in combined dosage form

Abstract

From BCS solubility study, pH 6.8 Phosphate Buffer was selected as a dissolution medium and dissolution parameter established. HPLC method for dissolution testing of OLM and MET in tablet formulation was developed and validated. All system suitability parameters were passed in acceptable range. Linearity of the developed method was near to 1.0 within the specified range. %RSD was found to be less than 2 for repeatability. %Recovery for both the drugs was found to be within 98-102% across all levels. These results indicate that the developed method is accurate, precise, specific, robust and less time consuming It can be used in the routine newlinequality control of marketed dosage form. Total run time per sample analysis was 4 minutes. Stability indicating UHPLC method for assay testing of OLM and MET in tablet formulation was developed and validated. All system suitability parameters were passed in acceptable range. Peak purity of all three drugs was passed in forced degradation samples and mass balance was found to be within the range of 95-105%. Linearity of the developed method was near to 1.0 within the specified range. %RSD was found to be less than 2 for repeatability. %Recovery for newlineboth the drugs was found to be within 98-102% across all levels. These results indicate that the developed method is accurate, precise, specific, robust and less time consuming. It can be used in the routine quality control of marketed dosage form. newlineA simple, precise bioanalytical UPLC Tandem Mass Spectroscopy gradient elution method newlinewas developed and validated for simultaneous estimation of Olmesartan Medoximil (OLM) newlineand Metoprolol Succinate (MET) in human plasma. The quantitation carried out using newlineShimadzu Shimpack-C18 GIST AQ (50 mm X 2.1 mm, 1.9 and#956;m) column and the mobile phase newlineA comprises of 0.1% formic acid and mobile phase B as acetonitrile used for gradient elution. Analysis completed within run time of 4 min at the mobile phase flow rate of 0.3 mL/min.