目的 建立盐酸非那沙星原料药中R,R 型异构体的HPLC 测定方法.方法 采用Chiralpak AY-H 手性色谱柱(250mm×4.6 mm,5 μm);正庚烷–异丙醇–二乙胺(75:25:0.1)为流动相;体积流量为1.0 mL/min;柱温35 ℃;检测波长为295 nm;进样量10 μL.结果 盐酸非那沙星在101.2～813.1 ng/mL、R,R 型异构体在115.6～817.8 ng/mL 与峰面积的线性关系良好.R,R 型异构体平均回收率为100.31%,RSD 值为1.1%(n＝9).结论 建立的盐酸非那沙星R,R 型异构体HPLC法拆分检查法方便、准确,能有效地控制盐酸非那沙星的质量.

Objective To develop an HPLC method for determination of R,R isomer in finafloxacin hydrochloride active pharmaceutical ingredient. Methods The separation was performed on a Chiralpak AY-H column (250 mm × 4.6 mm, 5 μm) with n-heptane-isopropanol-diethylamine (75 :25:0.1) as mobile phase. The flow rate was 1.0 mL/min with injection volume of 10 μL, the column temperature was 35 ℃, and the detection wavelength was set at 295 nm. Results Finafloxacin hydrochloride and R,R isomer had good linearity in the ranges of 101.2-813.1 ng/mL and 115.6-817.8 ng/mL. The average recovery of R,R isomer was 100.31% with RSD 1.1% (n=9). Conclusion The method is convenient and accurate for split check of R,R-finafloxacin hydrochloride isomer, which can be used in quantity control for finafloxacin hydrochloride.