目的 建立鹽酸非那沙星原料藥中R,R 型異構(gòu)體的HPLC 測定方法.方法 采用Chiralpak AY-H 手性色譜柱(250mm×4.6 mm,5 μm);正庚烷–異丙醇–二乙胺(75:25:0.1)為流動(dòng)相;體積流量為1.0 mL/min;柱溫35 ℃;檢測波長為295 nm;進(jìn)樣量10 μL.結(jié)果 鹽酸非那沙星在101.2～813.1 ng/mL、R,R 型異構(gòu)體在115.6～817.8 ng/mL 與峰面積的線性關(guān)系良好.R,R 型異構(gòu)體平均回收率為100.31%,RSD 值為1.1%(n＝9).結(jié)論 建立的鹽酸非那沙星R,R 型異構(gòu)體HPLC法拆分檢查法方便、準(zhǔn)確,能有效地控制鹽酸非那沙星的質(zhì)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.