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The quality of a medicine depends not only on the active pharmaceutical ingredient but also on the control of unwanted substances that may be present in it. Such substances, commonly called impurities, can arise during synthesis, processing, storage, or de gradation. Their presence may affect the safety, stability, and quality of a medicine. This paper presents a study on the development and validation of analytical methods for impurity profiling in selected antiviral and antidiabetic drugs. The work focuses on ultraviolet (UV) spectrophotometry and high - performance liquid chromatography (HPLC), using oseltamivir, ritonavir, metformin hydrochloride, and glipizide as the selected drugs. UV methods, including area - under - the - curve and first - derivative approaches , are described alongside an improved gradient HPLC method. The reported validation parameters include linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness, and solution stability. The reported UV calibration results show coefficients of determination close to 0.999 for the individual drugs. The HPLC method reports correlation coefficients greater than 0.999 , recovery values from 98.2% to 101.6% , and low relative standard deviation values in precision testing. These results suggest that the developed methods may be suitable for routine analytical evaluation within the scope tested. The paper also discusses the importance of method validation, the limits of the reported work, and possible directions for future research. The findings should be interpreted in relation to the selected compounds and experimental conditions rather than assumed to apply to every drug or formulation
Official certificate associated with this published GREEN research paper.
Use the official IRED article page when sharing or referencing this publication.