目的 建立HPLC法測定安立生坦中R異構(gòu)體的方法。方法 采用HPLC法, 用硅膠鍵合蛋白質(zhì)型手性色譜柱ULTRON ES-OVM(150 mm×4.6 mm, 5 μm);以0.02 mol/L磷酸二氫鉀溶液(用磷酸調(diào)節(jié)pH至4.0)-乙腈(80:20)為流動相;檢測波長220 nm;柱溫30 ℃;體積流量為1.0 mL/min;進(jìn)樣體積20 μL。結(jié)果 安立生坦R異構(gòu)體在0.501～4.008 μg/mL與峰面積線性關(guān)系良好(r=0.999 3), 平均回收率為98.62%, RSD值為2.82%(n=12)。結(jié)論 本法操作簡便快速, 結(jié)果準(zhǔn)確可靠, 可用于安立生坦中R異構(gòu)體的控制。

Objective To establish an HPLC method for the determination of R optical isomer in ambrisentan. Methods The HPLC was performed on a ULTRON ES-OVM column (250 mm × 4.6 mm, 5 μm); potassium dihydrogen phosphate solution (0.02 mol/L, adjusted to pH 4 with phosphoric acid)-acetonitrile, 80:20 as mobile phase; detection wavelength, 220 nm; column temperature, 30 ℃; flow rate, 1 mL/min; volume of sample, 20 μL. Results A good linear relationship was obtained in the range of 0.501—4.008 μg/mL (r=0.999 3), and the average recovery was 98.62% with RSD of 2.82% (n = 12). Conclusion The method is convenient, rapid, accurate, and can be used for the determination of R optical isomer in ambrisentan.