Objective To establish an HPLC method for separating and determining the
enantiomers of
pazufloxacin mesylate.Methods By optimizing factors which affect the
chiral separation,the pH value of the mobile phase, the organic modifiers,chiral additives,and stationary phases,the optimum condition for chiral separation were selected.The enantiomers separation was carried out on Shimandzu ODS column(150mm×6.3mm,10μm),and methanol-phenylalanine solution(containing 8
mmol/L L-phenylalanine and 6.3 mmol/L copper sulphate,adjusted to pH=3.5 with sodium hydroxide solution)(30∶70) as the chiral mobile phase,detecting on wavelength at 332nm. Results The two enantiomers could be baseline separated,and the resolution was higher than 1.9.Calibration graphs were constructed in the range of 25～250μg/ml for S-(-)-and R-(+)-enantiomer,
respectively.The linear regression equations are:Y=1.38×105X-130.9 (r=0.9998)and Y=1.26×105X-60.6 (r=0.9998),respectively.The detection limits obtained by S/N=3 were 1.2ng for S-(-)-and 1.5ng for R-(+)-
Enantiomer,respectively.Conclusions The proposed method was simple,sensitive,accurate and reproducible,and it can be used for the quality control of the pazufloxacin mesylate enantiomers.
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