A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Telmisartan (TEL) and Azelnidipine (AZE) in fixed-dose combination formulations. Chromatographic separation was achieved on an Inertsil ODS C18 column (250 × 4.6 mm, 5 μm) using phosphate buffer (pH 3.0) and acetonitrile in a 70:30 (v/v) ratio as the mobile phase at a flow rate of 1.0 mL/min. Detection was carried out at 225 nm with a 20 μL injection volume. The method was validated in accordance with ICH Q2 (R1) guidelines and met all criteria for system suitability, linearity, precision, accuracy, sensitivity, robustness and stability-indicating capability. TEL and AZE eluted at 2.798 and 3.587 minutes, respectively, with resolution values greater than 2.0 and tailing factors not exceeding 1.2. Calibration curves were linear over the ranges of 100–500 μg/mL for TEL and 20–100 μg/mL for AZE, both showing correlation coefficients of 0.999. Accuracy studies demonstrated recoveries between 98.5% and 100.1%, while precision results confirmed reproducibility with %RSD below 2%. The method exhibited excellent sensitivity, with LOD and LOQ values of 3.72 and 7.40 µg/mL for TEL and 0.0242 and 0.0202 µg/mL for AZE, respectively. Forced degradation under acidic, alkaline, oxidative, thermal and photolytic conditions confirmed that degradation products were well resolved from the analyte peaks, demonstrating the stability-indicating power of the method. The proposed RP-HPLC method is simple, accurate, precise and robust, making it highly suitable for routine quality control, stability testing and regulatory applications of TEL and AZE in bulk and pharmaceutical dosage forms.
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