Document Detail

Stability-Indicating RP-LC Method for the Determination of Vildagliptin and Mass Spectrometry Detection for a Main Degradation Product.
MedLine Citation:
PMID:  22511486     Owner:  NLM     Status:  In-Data-Review    
A simple, precise and stability-indicating reversed-phase liquid chromatography method was developed and validated for the determination of vildagliptin (VLG) in pharmaceutical dosage form. The chromatographic separation was obtained within 6 min and was linear in the range of 20-80 µg/mL (r(2) = 0.9999). Limit of detection and limit of quantitation were 0.63 and 2.82 µg/mL, respectively. The method was validated in accordance with International Conference on Harmonization acceptance criteria for specificity, linearity, precision, accuracy, robustness and system suitability. Stress studies were carried out and no interference of the degradation products was observed. The excipients did not interfere in the determination of VLG. Furthermore, the main degradation product obtained from the stress studies (thermal, oxidative and alkaline hydrolysis) was evaluated for mass spectrometry and its molecular structure was predicted. The proposed method was successfully applied for the quantitative analysis of VLG in tablet dosage form, which will help to improve quality control and contribute to stability studies of pharmaceutical tablets containing this drug.
Amanda Thomas Barden; Bárbara Salamon; Elfrides Eva Sherman Schapoval; Martin Steppe
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of chromatographic science     Volume:  50     ISSN:  1945-239X     ISO Abbreviation:  J Chromatogr Sci     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0173225     Medline TA:  J Chromatogr Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  426-32     Citation Subset:  IM    
Postgraduate Program in Pharmaceutical Sciences, Federal University of Rio Grande do Sul, Porto Alegre-RS, Brazil.
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