HPLC法测定法罗培南钠的差向异构体及相关杂质  

Determination of Epimer and Related Impurities of Faropenem Sodium by HPLC

作　　者：曲喜龙 王夕婷 于海军 李铁健 张贵民 QU Xi-long;WANG Xi-ting;YU Hai-jun;LI Tie-jian;ZHANG Gui-min(National chiral Pharmaceutical Engineering and Technology Research Center,Lunan Pharmaceutical Group Co,Ltd.,Linyi 276006;Shandong New Time Pharmaceutical Co.Ltd.,Linyi 273400,China)

机构地区：[1]鲁南制药集团股份有限公司,国家手性制药工程技术研究中心,山东临沂276006 [2]山东新时代药业有限公司,山东临沂273400

出　　处：《海峡药学》2021年第4期87-91,共5页Strait Pharmaceutical Journal

摘　　要：目的建立RP-HPLC法测定法罗培南钠中的差向异构体及其它杂质。方法采用YMC Triart C 18(250 mm×4.6 mm,3μm)色谱柱,流动相采用乙腈-0.01 mol·L^(-1)甲酸铵溶液(甲酸调pH为3.5),梯度洗脱,流速1.0 mL·min^(-1),检测波长240 nm。结果在选定的色谱条件下,主峰与差向异构体及其它各杂质峰均能良好分离,差向异构体、杂质A、杂质B、杂质C和法罗培南分别在0.44~5.46μg·mL^(-1)(r=0.9996)、0.39~4.85μg·mL^(-1)(r=0.9998)、0.42~5.26μg·mL^(-1)(r=1.0000)、0.39~4.82μg·mL^(-1)(r=0.9999)、0.38~4.70μg·mL^(-1)(r=0.9999)浓度范围内与峰面积呈良好线性关系。差向异构体与各杂质的定量下限分别为2.68、1.12、1.58、4.82 ng,平均回收率(n=9)分别为99.48%、99.88%、97.88%、98.01%。结论经方法学验证,本法灵敏度高、专属性好,可用于法罗培南钠的有关物质测定。OBJECTIVE To establish an RP-HPLC method for the determination of epimer and other impurities of faropenem.METHODS The separation was achieved by using a gradient elution system of acetonitrile-0.01 mol·L^(-1)ammonium formate solution(pH was adjusted to 3.5 with formic acid)and YMC Triart C 18 column(250 mm×4.6 mm,3μm)at flow rate of 1.0 mL·min^(-1),with detection at 240 nm.RESULTS Epimer and other impurities were completely separated from the principal component.The calibration curves for epimer,impurity A,impurity B,impurity C,were linear in the range of 0.44-5.46μg·mL^(-1)(r=0.9996),0.39-4.85μg·mL^(-1)(r=0.9998),0.42-5.26μg·mL^(-1)(r=1.0000),0.39-4.82μg·mL^(-1)(r=0.9999),0.38-4.70μg·mL^(-1)(r=0.9999),respectively.The limits of quantitation were 2.68,1.12,1.58,4.82ng,and the recoveries(n=9)were 99.48%,99.88%,97.88%,98.01%for epimer and other impurities,respectively.CONCLUSION The method is proved that it has good sensitivity and specificity,and it can be used for the quality control of faropenem.

关 键 词：法罗培南钠 差向异构体 有关物质 高效液相色谱 

分 类 号：R927[医药卫生—药学]