Simultaneous Estimation of Aspirin and Vonoprazan in Active Pharmaceutical Ingredient and pharmaceutical formulation by RP-HPLC

Abstract

A reliable, precise, and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Aspirin and Vonoprazan in bulk drug and pharmaceutical formulations. Chromatographic separation was achieved using a Phenomenex C18 column with a mobile phase consisting of 0.02 M potassium dihydrogen phosphate (KH₂PO₄), acetonitrile, and water in a 40:40:20 (v/v/v) ratios, adjusted to pH 4.0 with orthophosphoric acid. The method showed good linearity over concentration ranges of 10–50 μg/mL for Aspirin and 2–10 μg/mL for Vonoprazan with correlation coefficients greater than 0.999. Validation in accordance with ICH Q2 (R1) guidelines confirmed high specificity, accuracy, precision with %RSD < 2, robustness, and suitable limits of detection and quantification. The method was successfully applied to marketed combined dosage forms, proving its applicability for routine quality control.