RP-HPLC法测定头孢他美钠的含量及有关物质  

Determination of cefetamet sodium and its related substances by RP-HPLC

作　　者：任凤英[1] 黎鹏 李直[1] 宋艳霞[1] 李强[1] 李波[1] 

机构地区：[1]中国医药集团总公司四川抗菌素工业研究所,成都610052 [2]成都樵枫科技发展有限公司,成都610041

出　　处：《中国抗生素杂志》2012年第12期916-919,923,共5页Chinese Journal of Antibiotics

摘　　要：目的建立反相高效液相色谱法测定头孢他美钠的含量和有关物质。方法采用Hypersil BDS C18柱（250mm×4．6mm，5μm），以0．013mmol／L庚烷磺酸钠、0．02mol／L磷酸二氢钾溶液-甲醇（75：25，用10％磷酸调pH值至3．4）为流动相；检测波长为263nm；柱温为35℃。结果头孢他美钠浓度在0．1-335．2μg／mL范围内，峰面积与浓度线性关系好r=0．9999（n=8），最低检出限为0．0004μg（S／N=3），定量限为0．002p．g（S／N=10）。结论该法简便、准确、灵敏度高，专属性强，可以用于头孢他美钠含量测定和有关物质检查。Objective To establish an RP-HPLC method for determination of cefetamet sodium and its related substances. Methods The chromatographic separation of cefetamet sodium was performed on an Hypersil BDS C18 column with a mobile phase consisting of 0.013mmol/L sodium heptanesulfonate, 0.02mol/L potassium dihydrogen phosphate buffer-methanol （75：25, at pH 3.4 adjusted with 10% phosphoric acid）. The detection was monitored at 263mn, and the column temperature was maintained at 35 ℃. Results The calibration curve of cefetamet sodium was linear in range of 0.1-335.2 μg/mL with the correlation coefficient of 0.9999（n=8）. The limit of detection is 0.0004μg （S/N=3）, the limit of quantitation is 0.002μg （S/N=10）. Conclusions The method is simple, rapid, sensitive and specific, and can be used for determination ofcefetamet sodium and its related substances.

关 键 词：头孢他美钠 含量 有关物质 反相高效液相色谱 

分 类 号：R927.2[医药卫生—药学]