development and validation of chiral hplc method for identification and quantification of (r)-enantiomer in ezetimibe手性高效液相色谱方法的开发和验证(r)对映体的识别和量化ezetimibe.pdfVIP

American Journal of Analytical Chemistry , 2012, 3, 478-483 /10.4236/ajac.2012.37063 Published Online July 2012 (http://www.SciRP.org/journal/ajac) Development and Validation of Chiral HPLC Method for Identification and Quantification of (R)-Enantiomer in Ezetimibe Kameswara Rao Chimalakonda, Venkatanarayana Gudala, Madhusudhan Gutta, Srinivasulu Polisetty, Sai Venkata Srinivas Koduri Inogent Laboratory, Jawaharlal Nehru Technological University, Hyderabad, India Email: Kameswararao_scientist@yahoo.co.in Received May 6, 2012; revised May 26, 2012; accepted June 11, 2012 ABSTRACT A normal phase enantioselective high performance liquid chromatographic method was developed for enantiomeric resolution of Ezetimibe it reduces the overall delivery of cholesterol to the liver. The enantiomers of Ezetimibe were resolved on a Chiral Pak AS-H (250 × 4.6 mm, 5 µm) column using a mobile phase system containing n-hexane, etha- nol, 2-propanol and trifloroacetic acid (84:12:4:0.1 v/v). The resolution between enantiomers was found to be more than 2.0. The limit of detection and limit of quantification of (R)-enantiomer were found to be 0.2 µg/mL and 0.5 µg/mL, respectively, for 10 µL injection volume. The sample solution and mobile phase were found to be stable for at least 48 h. The final optimized method was successfully applied to separate (R)-enantiomer from Ezetimibe and was proven to be reproducible and accurate for the quantitative determination of (R)-enantiomer in bulk drugs. Keywords: Ezetimibe; (R)-Enantiomer; Identification; Quantification and Validation 1. Introduction of cholesterol through the intestinal wall. This reduces