Analytical method development and validation of vildagliptin

Author: 
Kondaviti Sahini., Chandanam Sreedhar., Sreenivas Rao T and Akkamma H.G

In the present work, a rapid, accurate and precise RP-HPLC method was developed for the estimation of Vildagliptin in tablet dosage form 50mg by selecting various chromatographic parameters.

A new method was developed using 250×4.6mm, 5µm, reverse phase C18 column with mobile phase of 80 volumes of Buffer and 20 volumes of Acetonitrile and 80 volumes of methanol and 20 volumes of water as diluent. Flow rate was 1.1ml/min with PDA detection at 210nm and the injection volume was set at 10µL with about 7.0 minutes of runtime.

The method was validated by using various validation parameters like accuracy, precision, linearity, specificity and stability in analytical solution and robustness. These results show the method could find practical application as a quality control tool for analysis of the drug in its tablet dosage forms in quality control laboratories.

Page: 
2919-2922
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DOI: 
http://dx.doi.org/10.24327/23956429.ijcmpr20180367
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