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.
������, ����, ����, ���Ķ�, ������, ����Ȫ, ������. ������������ע��Һ���й����ʲⶨ�����ıȽ�[J]. �й�ҩѧ��־, 2017, 52(20): 1795-1800.
LIU Zhao-zhen, LI Min, HOU Jin-feng, LI Wen-dong, WANG Jun-qiu, CHE Bao-quan, YANG Wen-liang. Comparison of Analytical Methods for Detection of Related Substances of Etimicin Sulfate Injection. Chinese Pharmaceutical Journal, 2017, 52(20): 1795-1800.
XUE C X, ZHAO W J, LU Y F. Improved synthesis of etimicin sulfate [J]. Qilu Pharm Aff(��³ҩ��), 2005, 24(2):106-109.
[2]
YUAN Y Z, ZHANG M, FAN X L, et al. Impurity profiling ofetimicin sulfate by liquid chromate graphy ion-trap massspectrometry[J]. J Pharm Bio Anal, 2012, 70:212-223.
LIU L Y,LIU X.An innovative universal detector-corona charged aerosol detector[J]. Mod Sci Instrum(�ִ���ѧ����), 2011, 5(10):141-143.
[5]
YUAN Y Z, CHOPRA S, DENG X L, et al. Analysis of micronomicinby liquid chromatography with pulsed electrochemicaldetection[J]. J Chromatogr A, 2013, 1295:90-98.
[6]
XI L L, WU G F, ZHU Y. Analysis of etimicin sulfate by liquid chromatography with pulse amperometricdetection[J]. J Chromatogr A, 2006, 1115(1-2):202-207.
[7]
WU Y N, ZHAO W, ZHU X Y, et al. Determination of related substances in etimicin sulfate injection and etimicin and sodium chloride injection by LC-PED[J]. Chin J Antibiot(�й���������־), 2016, 41(8):618-623.
[8]
WANG Y, WANG M J, YAO S C, et al. The application and outlook of electrochemical detector (ECD)in the Chinese Pharmacopeia, the US Pharmacopeia and the European Pharmacopeia [J]. Chin J Antibiot(�й���������־), 2012, 37(11):801-805.
[9]
LIU Y,LI Q. Application of ion chromatography method in analysis of antibiotics[J]. Chin J Pharm Anal(ҩ�������־), 2012, 32(1):179-185.
[10]
ZHANG F M, WANG J.The determination of HPLC method for the kanamycin and sulfate in amikacinsulfate using charged aerosol detector[J]. Chin J Antibiot(�й���������־), 2015, 40(5):354-358.
[11]
SHIN S I, JUN Z M, TOSHIMASA T. Direct detection method of oligosaccharides by high performance liquid chromatograph with charged aerosol detection[J]. Biomed Chromatogr, 2007, 21(4):338-342.
[12]
ZHU X Y, WU Y N, ZHAO W, et al. Determination of related substances in etimicin sulfate andsodium chloride injection by HPLC-PAD[J]. Chin J Pharm Anal(ҩ�������־), 2013, 33(12):2151-2155.
[13]
YUAN Y Z,WUY N,ZHAO W, et al. Identification of the related substances in etimicin sulfate detected under the condition of Chinese Pharmacopoeia 2010 by LC/MSn with propionic acid enhanced electrospray ionization[J]. Chin Pharm J(�й�ҩѧ��־),2015, 50(20):1790-1796.
[14]
YUAN Y Z, ZHANG M, QIAN W, et al. Rapid characterization of the related substances in netilmicin sulfate sample by HPLC-ESI-IT-MS[J]. Chin Pharm J(�й�ҩѧ��־),2015, 50(18):1428-1433.
2017, Vol. 52 
