HPLC法测定中间体7-TACA含量和有关物质  

Determination of Intermediate 7-TACA Content and its Related Substances by HPLC

作　　者：邓思思[1] 唐克慧[1] 李喆宇[1] 张静霞[1] 王宇弛 徐明琴[1] 张春然[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4期171-175,共5页World Notes on Antibiotics

摘　　要：目的建立有效、简便、快速的高效液相色谱法测定中间体7-氨基-3-（1，2,3．三唑-4-硫代）甲基-头孢环-4-羧酸（7-TAcA）的含量和有关物质；方法色谱柱：C18色谱柱，流动相：0．03m01／L磷酸二氢钾溶液-乙腈（95：5），流速为1．OmL／min，检测波长：272nm，柱温35℃，进样量20μL；结果7-TACA在1．00~794．00μg／mL浓度范围内与峰面积呈良好的线性关系，Y=4×107X-53694，n=8，相关系数r=0．9999。最低检出浓度为0．6ng／mL，最小定量浓度为0．6ng／mL。结论该方法为中间体7-TACA含量测定和有关物质检查提供了方便、灵敏、精确、可靠的方法。为成品的质量提供了保证。Objective To establish an effective, simple and fast HPLC method for determination content and related substances of intermediate 7-Amino-3-（1,2,3-triazol-4-ylthio）methyl cepha-losporanic acid（7-TACA）. Methods Column： C18 column with a mobile phase（0.03mol/Lphosphate monobasic potassium solution - acetonitrile （95 ： 5））. The flow rate was 1.0 mL/min, the detection wave length was 272nm, the column temperature was 35~C , the injection volume was 20 ~tL. Result 7-TACA within 1.00-794.00 ~tg/mL concentration range shows good linear relationship （n = 8）, Y=4× 107X-53694, r=0.9999. The lowest detectable concentration was 0.2ng/mL, the minimum detectable concentration was 0.1 ng/mL. Conclusion The method was convenient,sensitive,accurate and reliable for the determination of intermediate 7-TACA＇s content and related substances, which provided quality assurance for the end product.

关 键 词：7-TACA HPLC 中间体 

分 类 号：R978.1[医药卫生—药品]