目的系统比较电喷雾检测器、蒸发光散射检测器、脉冲安培生化学检测器3种方法测定依替米星注射液的有关物质,建立有关物质检测方法。方法建立的HPLC-CAD方法以0.2 mol·L~(-1)三氟乙酸-甲醇(95∶5)为流动相,流速为1.0 mL·min~(-1),柱温为30℃,雾化温度30℃,气压0.24 MPa,HPLC-ELSD和HPLC-PAD方法采用《中国药典》2015年版条件。结果 HPLC-CAD方法与HPLC-ELSD方法相比,分离度和灵敏度更高;与HPLC-PAD法比较,杂质测定结果更准确。结论建立的HPLC-CAD法分离能力强,检测出的杂质更多,可作为硫酸依替米星注射液有关物质测定的常规方法。 OBJECTIVE To compare three methods of electrospray ionization detector, evaporative light scattering detector and pulsed amperometric detector for the determination of etimicin injection and to establish a method for the determination of related substances. The HPLC-CAD method was established with 0.2 mol·L -1 trifluoroacetic acid-methanol (95: 5) as the mobile phase at a flow rate of 1.0 mL · min -1 with a column temperature of 30 ° C and a fog The temperature was 30 ℃ and the pressure was 0.24 MPa. The HPLC-ELSD and HPLC-PAD methods were used in the Chinese Pharmacopoeia 2015 edition. Results The HPLC-CAD method showed higher resolution and sensitivity than the HPLC-ELSD method. Compared with the HPLC-PAD method, the impurity determination results were more accurate. Conclusion The established HPLC-CAD method has the advantages of strong separation ability and more impurities detected, which can be used as a routine method for the determination of related substances in etimicin sulfate injection.