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Development, Validation and FTIR Characterization of Sitagliptin and Empagliflozin Using a Novel Analytical Method

  • Unique Paper ID: 176953
  • Volume: 11
  • Issue: 11
  • PageNo: 7166-7175
  • Abstract:
  • A simple, accurate, and precise UV spectrophotometric method was developed and validated for the estimation of Sitagliptin and Empagliflozin in physical mixture. The method was successfully evaluated for key validation parameters such as accuracy, precision, and linearity in accordance with ICH guidelines. The linearity was found to be satisfactory for both drugs, with correlation coefficients (R²) indicating a strong linear relationship. Accuracy was confirmed through recovery studies, with mean percentage recoveries falling within the acceptable range of 98–102%. Precision studies yielded low %RSD values, indicating good reproducibility. The method also demonstrated robustness and practicality, making it well-suited for routine quality control analysis. In addition, FTIR spectroscopy was employed to assess the functional groups and structural integrity of Sitagliptin and Empagliflozin. The FTIR spectra confirmed the presence of characteristic peaks, indicating no significant drug-excipient interaction and supporting the compatibility of the active pharmaceutical ingredients. The combination of UV spectrophotometric and FTIR analyses provides a comprehensive and efficient approach for the quality evaluation of Sitagliptin and Empagliflozin in pharmaceutical formulations.
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Cite This Article

  • ISSN: 2349-6002
  • Volume: 11
  • Issue: 11
  • PageNo: 7166-7175

Development, Validation and FTIR Characterization of Sitagliptin and Empagliflozin Using a Novel Analytical Method

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