This study presents the development and validation of a high-performance liquid chromatography (HPLC) method for the quantitative analysis of vildagliptin in pharmaceutical formulations. The method utilizes a C18 column with a mobile phase consisting of acetonitrile and pH 4.5 phosphate buffer (10:90, V:V), with UV detection at 200 nm. Method validation was performed according to ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, and robustness. Forced degradation studies were conducted to evaluate the stability of vildagliptin under various stress conditions, including acidic, basic, oxidative, and thermal environments. Compared to other chromatographic methods reported in the literature, this method provides enhanced sensitivity and reproducibility, making it highly suitable for routine quality control in pharmaceutical settings. The developed method is cost-effective and environmentally friendly due to the low organic solvent consumption.

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Development and Validation of an HPLC Method for the Analysis of Vildagliptin in Pharmaceutical Formulations

  • Minela Dacić,
  • Nina Avdić,
  • Maja Pašić-Kulenović,
  • Bekir Behlulović

摘要

This study presents the development and validation of a high-performance liquid chromatography (HPLC) method for the quantitative analysis of vildagliptin in pharmaceutical formulations. The method utilizes a C18 column with a mobile phase consisting of acetonitrile and pH 4.5 phosphate buffer (10:90, V:V), with UV detection at 200 nm. Method validation was performed according to ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, and robustness. Forced degradation studies were conducted to evaluate the stability of vildagliptin under various stress conditions, including acidic, basic, oxidative, and thermal environments. Compared to other chromatographic methods reported in the literature, this method provides enhanced sensitivity and reproducibility, making it highly suitable for routine quality control in pharmaceutical settings. The developed method is cost-effective and environmentally friendly due to the low organic solvent consumption.