Development and Validation of Chiral HPLC Method for Identification and Quantification of (R)-Enantiomer in Ezetimibe
- 1 Jawaharlal Nehru Technological University, Inogent Laboratory, Hyderabad, India
- 2 Jawaharlal Nehru Technological University, Inogent Laboratory, Hyderabad, India
- 3 Jawaharlal Nehru Technological University, Inogent Laboratory, Hyderabad, India
- 4 Jawaharlal Nehru Technological University, Inogent Laboratory, Hyderabad, India
- 5 Jawaharlal Nehru Technological University, Inogent Laboratory, Hyderabad, India
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.
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