Development And Validation Of Stability Indicating Rp-Hplc Method For Quantitative Estimation Of Metoprolol Succinate And Azelnidipine From Synthetic Mixture

Abstract

A new simple, precise, accurate and selective stability indicating RP-HPLC method has been developed and validated for estimation of Metoprolol succinate and Azelnidipine in synthetic mixture. The method was carried out on Hypersil ODS C₁₈ 5µ column (250 x 4.6 mm) with a mobile phase consisting of Acetonitrile: 0.025 M KH₂PO₄ Buffer (70:30 v/v, pH adjusted to 3 with 10% Ortho phosphoric acid and flow rate of 1 mL/min. Detection was carried out at 228 nm. The retention time for Metoprolol succinate and Azelnidipine was found to be 3.281 min and 10.799 min, respectively. The Metoprolol succinate and Azelnidipine followed linearity in the concentration range of 25-125 µg/mL (r²= 0.9995) and 8-40 µg/mL (r²=0.9997) . The developed method was validated for linearity and range, accuracy, precision, and assay. Metoprolol Succinate and Azelnidipine was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Retention Time. The proposed method can be used for routine analysis of Metoprolol Succinate and Azelnidipine in synthetic mixture.