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.
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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.
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