Abstract

DEVELOPMENT AND VALIDATION OF UVSPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND METOPROLOL SUCCINATE IN THEIR DOSAGE FORM

Hitanshi Daraji* and Dr. Zarna Dedania

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Abstract

A Simple, precise and accurate spectrophotometric method has been developed for simultaneous estimation of Azelnidipine (AZL) and Metoprolol Succinate (MET) in pharmaceutical dosage form. This method was based on UV-spectrophotometric determination of two drugs, using absorbance correction method. It involves measurement of absorbances at two wavelengths 313nm (λmax of AZL) and 275.40nm (λmax of MET) in methanol. Linearity was observed in the concentration range of 5 – 25 μg/ml and 25 - 125 μg/ml for AZL and MET respectively. The accuracy and precision of the method was determined and validated. The method showed good reproducibility and recovery with % RSD less than 2. Method can be successfully applied for the routine analysis of AZL and MET in combined dosage form without any interference by the excipients. The method was validated as per ICH Q2 (R1) guideline and found to be accurately in estimating the drug substances in tablet dosage form.

Keywords: Azelnidipine, Metoprolol Succinate, Absorbance correction method, Method Validation.