Objective This study aimed to establish a quality control method for the contents of gentamicin C components and related substances in gentamycin sulfate and bismuth carbonate capsules.Methods HPLC-ELSD method was used.The column was GRACEApollo C18(250 mm×4.6 mm,5 μm),the mobile phase was 0.2 mol/L trifluoroacetic acid solution:methanol(96∶4,V/V),the flow rate was 0.6 mL/min,the column temperature was 30 ℃,the injection volume was 20 μL,the Waters low-temperature diverging evaporative light scattering detector was used,carrier gas flow was 40 psi,and the drift tube temperature was 55 ℃.Results The method was validated and performed well on the separation of gentamicin C components and other related substances.Good linearities were observed between the logarithmic values of each concentration and the corresponding chromatographic peak area for gentamicin,sisomicin and micronomicin with concentration ranges of 0.5～6 mg/mL,25～100 μg/mL and 25～100 μg/mL,respectively.Samples of 43 batches of gentamicin sulfate and bismuth carbonate capsules from 16 companies on the market were tested using the method that had already been set up.This gave information about the ingredients and other substances in the preparation product.Conclusion The method was developed and optimized on the basis of Chinese Pharmacopeia with the strengths of convenience,specificity and robustness.It is validated for the determination of the content and related substances of gentamicin C components in gentamycin sulfate and bismuth carbonate capsules.The results showed significant differences in the content and related substances in the capsules from different manufacturers and batches,which indicated substantial risks for medication safety.Therefore,it was suggested that the method be considered in the quality control of such capsules.
关键词
庆大霉素C组分/有关物质/HPLC-ELSD法/复方制剂/硫酸庆大霉素碳酸铋胶囊
Key words
Gentamicin C components/Related substances/HPLC-ELSD/Compound preparation/Gentamicin sulfate and bismuth carbonate capsules
维普
万方数据