摘要
目的:建立高效液相色谱法测定维生素C注射液有关物质的方法。方法:采用Venusil Hilic色谱柱(250mm×4.6 mm,5μm);流动相:醋酸铵(0.1 mol·L^(-1),用氨水调pH至6.8)-乙腈(24:76);流速:1.0 ml·min^(-1);检测波长:210 nm,进样量:20μl,柱温:30℃。结果:样品中的杂质能被很好检出,各杂质与主峰间的分离度良好,检测限为1ng。结论:该方法可以作为维生素C有关物质的控制。
Objective:To establish an HPLC method for the determination of the related substances in vitamin C injections.Method: A Venusil Hilic column(250 mm×4.6 mm,5μm) was used and the mobile phase was ammonium acetate(0.1 mol·L^(-1),adjusting pH to 6.8 with ammonia)-acetonitrile(24:76).The flow rate was 1.0 ml·min^(-1),the detection wavelength was 210 nm,the injection volume was 20μl,and the column temperature was 30℃.Result:Vitamin C and its related substances could be well separated. The limit of detection was 1 ng.Conclusion:The method can be used in the control of the related substances in vitamin C injections.
出处
《中国药师》
CAS
2013年第3期390-392,共3页
China Pharmacist