Comparison of Analytical Methods for Detection of Related Substances of Etimicin Sulfate Injection
- Author:
Zhao-Zhen LIU
1
Author Information
- Publication Type:Journal Article
- Keywords: Etimicin sulfate injection; HPLC-CAD; HPLC-ELSD; HPLC-PAD; Related substance
- From: Chinese Pharmaceutical Journal 2017;52(20):1795-1800
- CountryChina
- Language:Chinese
- Abstract: 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.
