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Research Article

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR IMPURITY PROFILING IN SELECTED ANTIVIRAL AND ANTIDIABETIC DRUGS

Author
Hetangi Mehulbhai Vaishnav
AffiliationResearch Scholar, Department of Chemistry, Surendrangar University, Wadhwan
Article ID: GREEN-2026-0020Research ArticleOctober 2026Volume 1Issue 3Certificate Available
DOI
Not Assigned
Keywords
Impurity profilingsynthetic organic drugsUV spectrophotometryHPLCmethod validationantiviral drugsantidiabetic drugspharmaceutical quality control
Article Summary

Abstract

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

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