Determination of the Enantiomers in Pregabalin Oral Solution by HPLC-CAD
Objective:To establish a method for the determination of enantiomers in Pregabalin oral solution.Methods:The chromatographic was performed on a column of 4.0 mm×150 mm,3 μm by CHIRALPAK ZWIX(+).The mobile phase was 0.01 mol/L ammonium acetate buffer(pH value 5.5)-ethanol(20 ∶ 80).The flow rate was 0.5 ml·min-1 with isocratic elution.The column temperature was 20℃.CAD was used as detector with the evaporation tube temperature of 35℃.Results:The resolution between the R-pregabalin peak and pregabalin peak,excipients peak was good.The limit of detection was 60 ng.The RSD of 12 samples was 3.3%.The concentration of R-pregabalin showed a good linear relationship with the peak area in the range of 2.99 μg·mL-1 to 22.39 μg·mL-1(r = 0.999 1).The average recovery was 99.8%(n = 9).Slightly changed the chromatographic conditions such as flow rate,column temperature,pH of acetate buffer and evaporation tube temperature had no effect on the detection results.Conclusion:The method has strong specificity,high sensitivity,high precision and good robustness,and can be used for the determination of pregabalin enantiomers in Pregabalin oral solution.
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