硫酸依替米星注射液中有关物质测定方法的比较  

Comparison of Analytical Methods for Detection of Related Substances of Etimicin Sulfate Injection

作　　者：刘照振[1] 李珉 侯金凤 李文东[1] 王俊秋[1] 车宝泉[1] 杨文良[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药学杂志》2017年第20期1795-1800,共6页Chinese Pharmaceutical Journal

摘　　要：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 and optimize the analytical methods for detection of related substances of etimicin sulfate injection.METHODS For the HPLC-CAD（charge aerosol detector） method,the mobile phase was 0.2 mol·L^-1 trifluoroacetic acid aqueous solution-methanol（95∶5）,the flow rate was 1.0 mL·min^-1 and the column temperature was maintained at 30℃.The nebulization temperature for the CAD was maintained at 30℃ and the gas pressure was 0.24 MPa.The HPLC-ELSD and HPLC-PAD methods adopted by the Ch.P 2015 were also used to detect the related substances of etimicin sulfate injection for the purpose of comparison.RESULTS Compared with the HPLC-ELSD method,the HPLC-CAD method showed higher selectivity and sensitivity;compared with the HPLC-PAD method,the results of the determination of the impurities were more accurate for the HPLC-CAD method.CONCLUSION The separation capability of the new HPLC-CAD method for detection of the related substances of etimicin sulfate injection is superior to HPLC-PAD and HPLC-ELSD methods and can detect more impurities,which is suitable for the quality control of etimicin sulfate injection.

关 键 词：电喷雾检测器 蒸发光散射检测器 脉冲安培电化学检测器 硫酸依替米星注射液 有关物质 

分 类 号：R917[医药卫生—药物分析学]