HPLC法检查左旋奥硝唑中异构体

Determination of dextroisomer in S-ornidazole substances byHPLC

目的 建立HPLC手性固定相法检查左旋奥硝唑（S-奥硝唑）中对映异构体杂质（R-奥硝唑）。方法 用Chiralpak IC为手性固定相,正己烷-异丙醇（体积比为85∶15）为流动相,流速为1.0mL·min-1,柱温为27℃,检测波长为310 nm。结果R-奥硝唑在质量浓度为0.10~0.35mg·L-1内线性良好（r=0.999 3）,方法回收率为95.9%-102.9%（RSD=2.5,n=9）。结论建立的方法可用于左旋奥硝唑中R-异构体杂质的检查。

Objective To develop an HPLC method for enantiomeric resolution of ornidazole, and detect the impurity of dextroisomer in S-ornidazole. Methods Chiralpak IC column（ cellulose-tris （3,5-dichlorophenyl- carbamate） ）was applied with mobile phase consisting of n-hexane-isopropanol （ V： V = 85：15 ）, the flow rate was 1.0 mL·min-1 ,column temperature was 27 ℃ and wavelength was 310 nm. The influences oforganic modifiers and column temperature on the retention and separation were studied. Results Linear range was 0. 10 - 0. 35 mg· L - 1 （ r = 0.999 3 ）. The average recovery was 95.9 % to 102.9 %. Conclusions The method is simple and rapid for the enantiomeric impurity determination of S-ornidazole substances.