丙二醇头孢曲嗪的有关物质检查  

Determination of Related Substances in Cefatrizine Propylene Glycol

作　　者：张静霞[1] 李喆宇[1] 徐明琴[1] 王宇驰 张春然[1] 唐克慧[1] 

机构地区：[1]成都大学四川抗菌素工业研究所,成都610052

出　　处：《国外医药（抗生素分册）》2015年第3期112-116,共5页World Notes on Antibiotics

基　　金："国家重大新药创制"科技重大专项(20112X09401-403)

摘　　要：目的 建立头孢曲嗪有关物质检查方法.方法 有关物质检查采用Ultimate XB-C18色谱柱（250×4.6mm,5μm）,以0.03mol/L的磷酸二氢钾溶液-乙腈（92∶8）为流动相,流速为1.0 mL/min,检测波长为272nm,柱温为35℃,进样体积为20μL.结果 头孢曲嗪与各有关物质分离良好;头孢曲嗪在1.01～808.64μg/mL浓度范围内,峰面积与浓度呈良好的线性关系,相关系数为1.0000,检测限为0.2 ng.丙二醇气相测定法线性良好,加样回收率为115.7％.结论 有关物质检查法快速、专属、准确、可靠,可有效测定目标化合物.Objective To establish a HPLC method for the determination of related substances in cefatrizine propylene glycol. Methods Separation was performed on a ultimate XB-C18 column （250×4.6 mm, 5μm）, the column temperature was maintained at 35℃. The mobile phase consisted of 92 volumes of 0.03 mol/Lpotassium dihydrogen phosphate buffer solution and 2 volumes of acetonitrile at the flow rate of 1.0 mL/min. The detection wavelength was at 272nm. The injection volume was 20 μL. Results Cefatrizine was completely separated from related substances. The calibration curve was linear within 1.01-808.64 μg/mL with a correlation coefficient of 1.0000. The lowest limit of detection was 0.2 ng. Propylene glycol gas chromatographic method with good linearity, recovery rate was 115.7%. Conclusion The methods is fast, selective, accurate and reliable, can be used for the determination of the target compounds.

关 键 词：头孢曲嗪 有关物质 丙二醇 

分 类 号：R978.11[医药卫生—药品]