Integrated Stability-Indicating RP-HPLC Strategy for Comprehensive Quality Control of a Phosphodiesterase-5 Inhibitor in Solid Pharmaceutical Dosage Forms

Abstract

This study develops an integrated stability-indicating RP-HPLC strategy for the quality control of a phosphodiesterase-5 inhibitor in solid pharmaceutical dosage forms. The proposed approach allows for the simultaneous evaluation of dosage, related substances, and dissolution performance within a single analytical protocol. Chromatographic separation was performed on a C18 column under optimized conditions, yielding sufficient resolution between the active ingredient and its degradation products within a brief analysis duration. The method was validated in accordance with ICH Q2(R2) guidelines by evaluating the parameters of specificity, linearity, accuracy, precision, sensitivity, and robustness. Forced degradation studies, carried out under acidic, alkaline, oxidative, and thermal, conditions confirmed its stability.