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目的:建立以高效液相色谱法测定医用生物蛋白胶中硫酸庆大霉素C组分含量的方法。方法:色谱柱为Agilent ZORBAX Eclipse XDB-C18,流动相为甲醇-醋酸-水(加入0.02mol·L-1庚烷磺酸钠溶液,70∶5∶25),梯度洗脱,检测波长为330nm,柱温为26℃,流速为1.0mL·min-1。结果:硫酸庆大霉素C组分间分离较好,线性范围为0.26~6.50μg(r=0.9998);平均回收率为90.0%,RSD=0.43%;最低检测限为0.368ng。结论:本方法准确可靠、简便易行,可用于相关制剂中硫酸庆大霉素C组分的含量测定。
Objective: To establish a method for the determination of gentamicin sulfate component in medical bioprotein glue by high performance liquid chromatography. Methods: The column was Agilent ZORBAX Eclipse XDB-C18. The mobile phase consisted of methanol-acetic acid-water (0.02mol·L -1 sodium heptanesulfonate, 70:5:25) gradient elution at a wavelength of 330nm The column temperature was 26 ℃ and the flow rate was 1.0 mL · min-1. Results: The separation of gentamicin sulfate was better with a linear range of 0.26-6.50μg (r = 0.9998). The average recovery was 90.0% with RSD of 0.43%. The minimum detection limit was 0.368ng. Conclusion: The method is accurate and reliable, simple and easy to use, and can be used to determine the content of gentamicin sulfate C component in the related preparations.