目的 建立测定原料药4，5，2'-三吗啉酰氧基-2，5'-二氯二苯甲酮（LF1）的含量及有关物质的RP-HPLC方法。方法 采用Diamonsil C₁₈（250 mm×4.6 mm，5 μm）色谱柱，乙腈-磷酸水（60：40，pH3.0）为流动相，检测波长230 nm，体积流量1 mL/min，柱温25℃。结果 主峰与杂质峰分离良好，LF1和杂质A分别在质量浓度1.0~100（r=0.999 8）和0.2~2.4 mg/L （r=0.999 6）线性关系良好，最低检测限分别为1和2 ng/mL，平均回收率分别为100.7%和102.0%。结论 本法简便、快速、准确，可用于LF1原料药的含量及有关物质的测定。

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.

国家自然科学基金（81473100）；国家重大专项（2017ZX09101003-001-017）；2017年山西省重点研发计划（重点）项目（201703D111033）