HPLC法测定注射用头孢他美钠的含量及有关物质

Determination of Content and Related Substances of Cefetamet Sodium for Injction by HPLC

目的 建立高效液相色谱法测定注射用头孢他美钠的含量和有关物质.方法 采用Thermo 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0.1～402.4μg/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0.4ng（S/N=3）,定量限为2ng（S/N=10）.结论 该法简便、准确、灵敏度高,专属性强,可以用于注射用头孢他美钠含量测定和有关物质检查.

Objective To establish an HPLC method for determination of content and related substances of cefetamet sodium for injection. Methods The chromatographic separation of 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 263nm, and the column temperature was maintained at 35 ℃. Results The calibration curve of cefetamet sodium was linear in range of 0.1-402.4 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 of content and its related substances of cefetamet sodium for injection.