目的 建立測(cè)定原料藥4，5，2'-三嗎啉酰氧基-2，5'-二氯二苯甲酮（LF1）的含量及有關(guān)物質(zhì)的RP-HPLC方法。方法 采用Diamonsil C₁₈（250 mm×4.6 mm，5 μm）色譜柱，乙腈-磷酸水（60：40，pH3.0）為流動(dòng)相，檢測(cè)波長230 nm，體積流量1 mL/min，柱溫25℃。結(jié)果 主峰與雜質(zhì)峰分離良好，LF1和雜質(zhì)A分別在質(zhì)量濃度1.0~100（r=0.999 8）和0.2~2.4 mg/L （r=0.999 6）線性關(guān)系良好，最低檢測(cè)限分別為1和2 ng/mL，平均回收率分別為100.7%和102.0%。結(jié)論 本法簡便、快速、準(zhǔn)確，可用于LF1原料藥的含量及有關(guān)物質(zhì)的測(cè)定。

Objective This paper aims to establish a RP-HPLC method to determine the content of 4,5,2'-trimorpholinyl acyloxy-2,5'-dichlorobenzophenone (LF1) and its related substances.Methods The HPLC method was explored on Diamonsil C₁₈ (250 mm×4.6 mm, 5 μm) with acetonitrile-phosphoric acid water (60:40, pH 3.0) as the mobile phase. The detection wavelength was 230 nm, the flow rate was 1 mL/min and the column temperature was 25℃. Results The LF1 was well separated from the impurities, respectively. The calibration curves of LF1 and impurity A showed good linear relationship within 1.0-100 (r=0.999 8) and 0.2-2.4 mg/L (r=0.999 6), The lowest limit of detection for LF1 and impurity A were 1 and 2 ng/mL, and the average recoveries were 100.7% and 102.0%, respectively.Conclusion The established HPLC method is simple, rapid and accurate, and can be used for the determination of LF1 and its related substances.

國家自然科學(xué)基金（81473100）；國家重大專項(xiàng)（2017ZX09101003-001-017）；2017年山西省重點(diǎn)研發(fā)計(jì)劃（重點(diǎn)）項(xiàng)目（201703D111033）