QUANTIFICATION OF VILDAGLIPTIN IN TABLETS USING HIGH LIQUID-PERFORMANCE CHROMATOGRAPHY

Abstract

The study aimed to establish a fast, simple and economical determination procedure for vildagliptin content in tablets by reverse phase high-performance liquid chromatography (Rp-HPLC). Research method: Chromatographic conditions affecting vildagliptin analysis, such as solvent system, sample processing and optimization of chromatographic conditions, and mobile phase ratio... were investigated. After determining the appropriate chromatographic parameters, the analytical process was validated according to Circular No. 32/2018/TT-BYT on regulations for marketing authorization of drugs and medicinal ingredients, including a survey of systemic suitability, specificity, the limit of quantification, limit of detection, linearity, accuracy, and precision. The analytical method showed a linear range from 12.5 to 100 µg/mL, and the limit of quantification was 1.21 µg/mL. The results of this study can be used as a routine procedure to analyze, control and test vildagliptin stability in tablet formulations.