Compatibility and stability of valsartan in a solid pharmaceutical formulation

Authors

  • Tamíris Amanda Júlio Federal University of Alfenas; Institute of Chemistry; Laboratory of Pharmaceutical Analysis and Characterization
  • Igor Fernando Zâmara Federal University of Alfenas; Institute of Chemistry; Laboratory of Pharmaceutical Analysis and Characterization
  • Jerusa Simone Garcia Federal University of Alfenas; Institute of Chemistry; Laboratory of Pharmaceutical Analysis and Characterization
  • Marcello Garcia Trevisan State University of Campinas; National Institute of Science and Technology of Bioanalytical

DOI:

https://doi.org/10.1590/S1984-82502013000400003

Abstract

Valsartan (VAL) is a highly selective blocker of the angiotensin II receptor that has been widely used in the treatment of hypertension. Active pharmaceutical ingredient compatibility with excipients (crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose and titanium dioxide) is usually evaluated in solid pharmaceutical development. Compatibility and stability can be evaluated by liquid chromatography. Studies were performed using binary mixtures of 1:1 (w/w) VAL/excipient; samples were stored under accelerated stability test conditions (40 ºC at 75% relative humidity). The results indicate that VAL is incompatible with crospovidone and hypromellose, which reduced the VAL content and gave rise to new peaks in the chromatogram due to degradation products.

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Published

2013-12-01

Issue

Vol. 49 No. 4 (2013)

Section

Articles

License

All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.

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How to Cite

Compatibility and stability of valsartan in a solid pharmaceutical formulation . (2013). Brazilian Journal of Pharmaceutical Sciences, 49(4), 645-651. https://doi.org/10.1590/S1984-82502013000400003