A simple, accurate, and cost-effective UV spectrophotometric method was developed and validated for the estimation of Vonoprazan fumarate in tablet dosage form. The solvent system utilized was 0.1N hydrochloric acid, and the drug exhibited a maximum absorbance (λmax) at 281 nm. The method obeyed Beer–Lambert’s law within the concentration range of 10–50 μg/ml with a correlation coefficient (r²) of 0.9997, indicating excellent linearity. The assay value was found to be 100.3% w/v, within the acceptable range of 90–110%. Precision and accuracy studies yielded results of 99.86% and 99.88%, respectively. The LOD and LOQ were calculated to be 1.557 μg/ml and 4.719 μg/ml. Validation was carried out as per ICH guidelines for parameters such as linearity, accuracy, precision, robustness, and ruggedness, with %RSD values less than 2%, confirming the reliability of the method. The developed method proved to be simple, rapid, and precise, making it suitable for routine quality control analysis of Vonoprazan fumarate in pharmaceutical formulations.
Nithesh. et al. (Sat,) studied this question.
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