摘要
目的建立HPLC—ELsD测定硫酸庆大霉素有关物质及改进C组分的测量方法。方法色谱柱采用耐酸的c18柱（pH适应范围0．8-8．0），流动相为0．2mol／L的三氟醋酸-甲醇（92：8）；流速为0．6mL／min；用蒸发光散射检测器检测，漂移管温度110℃，载气为2．8L／min。结果硫酸庆大霉素各组分与有关物质分离完全，可用外标法测定硫酸小诺霉素和西索米星的含量及庆大霉素C组分的含量。结论所用方法准确，灵敏度高，重现性好，可有效地控制药品的质量。
Objective To establish a method for the determination of gentamicin sulfate related substance and C substance by HPLC-ELSD. Methods A C18（pH0.8-8.0）column was used, the mobile was 0.2mol/L TFA- methanol（92： 8）, the detecter was ELSD. The temperature of drift was 110℃ and flow rate of carrier gas was 2.8L/ min. Ruslts The gentamicin sulfate was sperated from its related substance completely. The external reference method was used to quantitative the assay of micronomicin sulfate, sisomicin sulfate and C substance. Conclusion The method is accurate, sensible and reproducible. This method is suitable for the quality control.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2011年第10期775-777,共3页
Chinese Journal of Antibiotics
