%0 Journal Article
%T Validated Chiral Ultra Fast Liquid Chromatographic Method for Quantitative Analysis of Enantiomeric Vildagliptin
%A Chinta Srinivas
%A Husna Kanwal Qureshi
%A Ciddi Veeresham
%J American Journal of Analytical Chemistry
%P 429-439
%@ 2156-8278
%D 2021
%I Scientific Research Publishing
%R 10.4236/ajac.2021.1211026
%X A rapid, accurate, and precise chiral Ultra fast liquid chromatography (UFLC) method was developed and validated for enantiomeric separation of racemic vildagliptin and <i>S</i>-vildagliptin according to the guidelines of the International Conference on Harmonization (ICH). The chiral chromatographic separation was achieved with a mobile phase consisting of 20 mM borax buffer (pH 9.0 ¡À 0.05), ACN, and 0.1% Triethylamine (50:50:0.1, v/v/v) at a flow rate of 1 ml/min using a chiralcel OD-RH column, tris(3,5-dimethyl phenyl carbamate) (250 mm ¡Á 4.6 mm, 5 ¦Ìm) column. The UFLC analysis was monitored at 210 nm. The method showed good linearity with a regression coefficient (r<sup>2</sup>) of 0.999 in the range of 1 - 12 ¦Ìg/ml for <i>S</i>-vilda. The detection limit (LOD), quantitation limit (LOQ), and the average percentage recovery for <i>S</i>-vilda were found to be 0.024, 0.075 ¦Ìg/mL, and 99.19% to 100.4%, respectively. The percentages of relative standard deviation (% RSD) for intra- and inter-day precision were found to be 0.346% and 0.364%, respectively. The developed method proved to be reproducible as % RSD was &lt;2% and it had robustness within the acceptable limit. The percentage purity of pharmaceutical preparations of <i>S</i>-vilda was found to be 99.19 w/w. The proposed chiral method can be put in application for the enantiomeric purity determination of <i>S</i>-vilda formulations.
%K Standard Vildagliptin
%K &lt
%K i&gt
%K S&lt
%K /i&gt
%K -Vilda
%K Ultra Fast Liquid Chromatography
%K Method Development
%K Validation
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=113251