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Second-Order Derivative UV Spectrophotometric and RP-HPLC Methods for the Analysis of Vildagliptin and Application for Dissolution Study

Authors

  • Amanda Thomas Barden Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Rio Grande do Sul
  • Bruna L Piccoli Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Rio Grande do Sul
  • Nadia Maria Volpato Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Rio Grande do Sul
  • Martin Steppe Programa de Pós-Graduação em Ciências Farmacêuticas - Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22456/2527-2616.86511

Keywords:

Vildagliptin, Derivative UV Spectrophotometry, HPLC, Dissolution Method, Validation

Abstract

This study describes two analytical methods, by second-order derivative UV spectrophotometric by HPLC, for determination of vildagliptin, a drug used for treatment of type 2 Diabetes Mellitus that belongs to a therapeutic class called inhibitors of dipeptidyl peptidase 4. The methods were validated in accordance with ICH and USP requirements. Analyses by UV derivative method were performed at 220 nm, which was the zero crossing point of excipient solutions. HPLC was optimized and the analysis was carried out using a Zorbax Eclipse Plus RP-C8 column (150 mm × 4.6 mm, 5 μm), detection at 207 nm, and potassium phosphate buffer solution pH 7.0 : acetonitrile (85:15, v/v) as mobile phase. In dissolution test, the conditions used were 0.01 mol L-1 hydrochloric acid in 900 mL of dissolution medium, USP apparatus 2 (paddle) and 50 rpm stirring speed. Both methods were successfully applied for analysis of dissolution samples from marketed vildagliptin tablets.

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References

Mathieu, C; Diabetes, Obesity and Metabolism, 2009, 11(2): 9–17. DOI: https://doi.org/10.1111/j.1463-1326.2008.01033.x

Srinivasan, B.T., Jarvis, J., Khunti, K. and Davies, M.J.; Postgraduate Medical Journal, 2008, 84: 524-531. DOI: https://doi.org/10.1136/pgmj.2008.067918

Kahn, S.E., Haffner, S.M., Heise, M.A., Herman, W.H., Holman, R.R. and Jones, N.P.; New England Journal of Medicine, 2006, 355: 2427-2443. DOI: https://doi.org/10.1056/NEJMoa066224

Del, P.S., Bianchi, C. and Marchetti, P.; Diabetes & Metabolism, 2007, 23; 518-527. DOI: https://doi.org/10.1002/dmrr.770

Bolli, G., Dotta, F., Colin, L., Minic, B. And Goodman, M.; Diabetes, Obesity and Metabolism, 2009, 11: 589–595. DOI: https://doi.org/10.1111/j.1463-1326.2008.01023.x

Kamberi, M. and Tran, T.; Journal of Pharmaceutical and Biomedical Analysis, 2012, 70: 94-100. DOI: https://doi.org/10.1016/j.jpba.2012.05.038

Food and Drug Administration; Guidance for industry: immediate release solid oral dosage forms: scale-up and post-approval changes, U. S. Department of Health and Human Services, Center for Drug Evaluation and Research, Rockville, USA, 1995.

Rozet, E., Ziemonsa, E., Marinia, R.D., Boulanger, B. and Hubert, P.; Analytica Chimica Acta, 2012, 751: 44–51. DOI: https://doi.org/10.1016/j.aca.2012.09.017

Tomsu, D., Catalá Icardo, M. and Martínez Calatayud, J.; Journal of Pharmaceutical and Biomedical Analysis, 2004, 36: 549– 557. DOI: https://doi.org/10.1016/j.jpba.2004.07.009

Gorog, S.; Analytical Sciences, 2004, 20(5): 767-782. DOI: https://doi.org/10.2116/analsci.20.767

Karpinska, J.; Talanta, 2004, 64: 801-822. DOI: https://doi.org/10.1016/j.talanta.2004.03.060

El-Sayed, A.Y. and El-Salem, N.A.; Analytical Sciences, 2005, 21(6): 595-614. DOI: https://doi.org/10.2116/analsci.21.595

Rojas, F. and Ojeda, C.; Analytica Chimica Acta, 2009, 635: 22–44. DOI: https://doi.org/10.1016/j.aca.2008.12.039

The United States Pharmacopoeia, USP 39, United States Pharmacopeial Convention, Rockville, USA, 2016.

International Conference on Harmonization; ICH Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology, Geneva, Switzerland, 2005.

Sznitowska, M. and Stokrocka, M.; Acta Poloniae Pharmaceutica-Drug Research, 2007, 63(5): 401-405.

Barden, A.T., Salamon, B., Schapoval, E.E.S. and Steppe, M.; Journal of Chromatographic Science, 2012, 50: 426– 432. DOI: https://doi.org/10.1093/chromsci/bms024

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Published

14-09-2018 — Updated on 08-03-2026

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How to Cite

Thomas Barden, A., Piccoli, B. L., Volpato, N. M., & Steppe, M. (2026). Second-Order Derivative UV Spectrophotometric and RP-HPLC Methods for the Analysis of Vildagliptin and Application for Dissolution Study. Drug Analytical Research, 2(1), 46–53. https://doi.org/10.22456/2527-2616.86511 (Original work published September 14, 2018)

Issue

Vol. 2 No. 1 (2018)

Section

ORIGINAL ARTICLES

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