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FDA Policy Statement for the Development of New Stereoisomeric Drugs
A chiral high‐performance liquid chromatographic method was developed for the enantioseparation of a new insulinotropic drug of the glinide class with rapid onset. The chiral separation was performed on a Sumichiral OA‐3300 column (250 mm×4.6 mm, 5 µm) with methanol containing 0.05 mol/L ammonium acetate as the optimized mobile phase at detection wavelengh 210 nm. Baseline separation of the two enantiomers was obtained in 22 min with a resolution of 3.01. Calibration graphs were constructed in a range of 0.028–5.6 µg·mL−1 for S‐ and 0.03–6.0 µg·mL−1 for R‐(−)‐enantiomer, respectively. The linear correlation equations are: y=1.32×103x−2.54 (r=0.9997) for S‐enantiomer and y=1.15×103x−1.78 (r=0.9998) for R‐enantiomer, respectively. The limits of detection obtained by S/N=3 were 0.15 ng for S‐ and 0.10 ng for R‐enantiomer, respectively. RSD of the method was below 1.0% (n=5).
Chinese Journal of Chemistry – Wiley
Published: Jan 1, 2009
Keywords: ; ; ;
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