Stability indicating RP-LC-PDA method for the quantitative analysis of saxagliptin in pharmaceutical dosage form

Authors

  • Laís Engroff Scheeren Universidade Federal de Santa Maria
  • Ana Isa Pedroso Marcolino Universidade Federal de Santa Maria
  • Andréa Inês Horn Adams Universidade Federal de Santa Maria; Department of Industrial Pharmacy
  • Clarice Madalena Bueno Rolim Universidade Federal de Santa Maria; Department of Industrial Pharmacy

DOI:

https://doi.org/10.1590/S1984-82502015000200023

Abstract

;Saxagliptin is a potent and selective inhibitor of the enzyme dipeptidyl peptidase 4. It is effective in the treatment of type 2 diabetes mellitus because it stimulates the pancreas to produce insulin. In the present study, a liquid chromatography method was developed and validated to quantify the drug in tablets. This method was based on the isocratic elution of saxagliptin, using a mobile phase consisting of 0.1% phosphoric acid at pH 3.0 - methanol (70: 30, v/v) at a flow rate of 1 mL.min;-1; with UV detection at 225 nm. The chromatographic separation was achieved in 8 minutes on a Waters XBridge C18 column (250 mm x 4.6 mm, 5µm) maintained at ambient temperature. The proposed method proved to be specific and robust for the quality control of saxagliptin in pharmaceutical dosage forms, showing good linearity in the range of 15.0 - 100.0 µg.mL;-1; (r>;0.999), precision (RSD;

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Published

2015-06-01

How to Cite

Scheeren, L. E., Marcolino, A. I. P., Adams, A. I. H., & Rolim, C. M. B. (2015). Stability indicating RP-LC-PDA method for the quantitative analysis of saxagliptin in pharmaceutical dosage form. Brazilian Journal of Pharmaceutical Sciences, 51(2), 461-466. https://doi.org/10.1590/S1984-82502015000200023

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Articles