A novel stability indicating RP-hplc method development and validation for simultaneous estimation of alfuzosin hydrochloride and tadalafil
Abstract
A simple, rapid, accurate, precise, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Alfuzosin and Tadalafil in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved on a C18 column using a mobile phase of buffer and acetonitrile (65:35, v/v) at a flow rate of 0.6 mL/min under optimized conditions. The method was validated as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines for specificity, linearity, accuracy, precision, robustness, LOD, and LOQ. The method showed excellent linearity over the concentration range of 2–240 µg/mL for Alfuzosin and 1–120 µg/mL for Tadalafil, with correlation coefficients of 0.9992 and 0.9997, respectively. Accuracy was found in the range of 100.14–101.82% for Alfuzosin and 99.87– 101.37% for Tadalafil, while %RSD for precision was below 2%. The LOD and LOQ values were 0.03 and 0.05 µg/mL for Alfuzosin and 0.05 and 0.07 µg/mL for Tadalafil, respectively. Forced degradation studies confirmed the stability-indicating nature of the method. Therefore, the proposed method is suitable for routine quality control analysis of combined tablet dosage forms.
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