HPLC-ELSD法测定硫酸核糖霉素的含量和有关物质  

Determination of ribostamycin sulfate and its related substances by HPLC-ELSD

作　　者：刘海玲[1] 曹晓云[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国抗生素杂志》2010年第9期684-687,共4页Chinese Journal of Antibiotics

摘　　要：目的建立硫酸核糖霉素含量和有关物质的分析方法，为该类药提供质量控制标准。方法应用高效液相色谱．蒸发光散射检测器（HPLC-ELSD）法测定硫酸核糖霉素含量和有关物质。采用Agela Technologies Venusil ASB-C18 15nm（250mm×4．6mm，5μm）色谱柱，流动相为0．11mol／L七氟丁酸酐混合溶液[称取七氟丁酸酐45．1g，置1000mL量瓶中，加乙腈-四氢呋喃-水（8：5：87）混合溶液溶解并稀释至刻度，摇匀]，流速为0．8mL／min，漂移管温度为110℃，雾化气体流速为3．0L／min。结果在选定色谱条件下，核糖霉素和有关物质分离良好。核糖霉素在0．34～2．68μg范围内进样量对数与峰面积对数间呈较好的线性关系（r=0．9988），最低检出量为68ng。结论方法快速、简便，结果准确可靠，重现性好，可用于含量测定和有关物质检测。Objective To develop a new HPLC-ELSD method for the determination of ribostamycin sulfate and its related substances, and to supply a standard of quality control for ribostamycin sulfate. Methods Ribostamycin sulfate and its related substances were determined by HPLC-ELSD. The separation was performed on an Agela Technologies Venusil ASB-C18 15nm column（250mm×4.6mm, 5μm）. The mobile phase contained 0.1 lmol/L heptafluorobutyric anhydride[dissolution 45.1g of heptafluorobutyric anhydride in a mixture of acetonitriletetrahydrofuran-water（8 ： 5 ： 87）and add a mixture to produce 1000mL]. The flow rate was 0.8mL/min. The drift tube temperature was 110℃. The flow rate of gas was 3.0L/min. Results Good separations of ribostamycin and main related substances were achieved. The standard curve was linear in the range of 0.34-2.68gg（r=0.9988）.The lowest examination quantity was 68ng. Conclusion The method is rapid and simple, the results are accurate and reproducible. The method can be used to determination of ribostamycin sulfate and its related substances.

关 键 词：硫酸核糖霉素 高效液相色谱 蒸发光散射检测器 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]