Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

Archanaba V. Rathod, Ms. Ayushi Chokshi, Dr. Bhumi R. Patel*, Dr. Jaymin G. Patel, Ms. Janki A. Patel, Mr. Ronak N. Patel

Abstract

The present research describes the development and validation of a novel, stability-indicating RP-HPLC method for the simultaneous estimation of Azelnidipine and Metoprolol Succinate in a combined tablet dosage form. Given the DCGI approval of this synergistic combination in January 2024 and the lack of documented stability-indicating protocols, this study provides a necessary analytical solution. Chromatographic separation was performed on a Waters 2695 Alliance HPLC system using a C8 column (250×4.6 mm, 5 μm) with an optimized mobile phase consisting of Phosphate buffer (pH adjusted to 3.25 with OPA) and Acetonitrile in a 50:50 (v/v) ratio. The method was rigorously validated according to ICH guidelines and subjected to forced degradation studies under acidic, alkaline, thermal, and photolytic stress conditions. The results demonstrated effective resolution of the active pharmaceutical ingredients from their degradation products, confirming the method's specificity. This precise, accurate, and robust analytical tool is highly suitable for routine quality control and stability monitoring, ensuring the efficacy and safety of the formulation in the pharmaceutical industry.

Keywords: Azelnidipine, Metoprolol Succinate, RP-HPLC, Stability-indicating, Method Validation, Simultaneous Estimation.