DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF S (-) METOPROLOL SUCCINATE AND CLOPIDOGREL BISULPHATE IN BULK AND TABLET DOSAGE FORM

摘要

The objective of present work was to develop an UV spectrophotometric method for simultaneous determination of S (-) Metoprolol Succinate (S (-) MET) and Clopidogrel Bisulphate (CLOP) in bulk and tablet dosage form. Methanol was used as a common solvent for both drugs. This method was based on generation of simultaneous equations at 224 nm and 219 nm. Linearity for both drugs was found in the concentration range of 5-30 μg/ml. This method was validated as per International Conference on Harmonization (ICH) guidelines. Low values of %RSD for intra- and inter-day precision suggested reproducibility of the method. Satisfactory values of percent recovery indicated accuracy of the method. Sensitivity of the method was proved by low value of Limit of Detection and Limit of Quantitation. Assay results of marketed formulation were found to be 101.90% and 101.11% for S (-) MET and CLOP, respectively. Results suggest that the proposed method can be applied in routine quality control studies for assay of S (-) MET and CLOP in bulk and tablet dosage forms