DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR ESTIMATION OF VILDAGLIPTIN AND PIOGLITAZONE IN BULK DRUG AND DOSAGE FORM

Abstract

This thesis focuses on the design and approval of a reverse-phase high-performance liquid chromatography (RP-HPLC) technique for the simultaneous measurement of pioglitazone and vildagliptin in dose and bulk forms. The primary objectives include an extensive literature review to understand existing RP-HPLC methods for these drugs and identify gaps and limitations. The preliminary characterization of Vildagliptin and Pioglitazone involves assessing their color, odor, appearance, and solubility in methanol, as well as selecting appropriate analytical wavelengths. To ensure effective drug separation and quantification, the method development phase optimizes RP-HPLC parameters, including mobile phase composition, pH, column type, and temperature. To determine which detection wavelength is best for analysis, a variety of wavelengths are tested. Formulations that are sold and contain pioglitazone and vildagliptin are also assessed. In accordance with International Council for Harmonization (ICH) criteria, the developed RP-HPLC technique is verified to guarantee specificity, linearity, accuracy, precision, robustness, limits of detection (LOD) and quantitation (LOQ), and system adaptability. A stability and filtration assessment of the solution is part of the investigation. Vildagliptin and pioglitazone are quantified in pure bulk drug forms using the established technique; assay content is calculated and compared to theoretical values. To evaluate the solution stability of pioglitazone and vildagliptin under different circumstances, a stability study is carried out. By taking a thorough approach, the proposed method is guaranteed to be dependable and appropriate for routine drug analysis, both in dose and bulk forms.