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

??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.