HPLC法测定注射用盐酸头孢替安的有关物质  

Determination of related substances in Cefotiam Hydrochloride for Injection by HPLC

作　　者：王庆[1] 闫灵锐 费小琴 周艳婷[1] WANG Qing;YAN Lingrui;FEI Xiaoqin;ZHOU Yanting(Chongqing Shenghuaxi Pharmaceutical Limited Company,Chongqing 401336,China)

机构地区：[1]重庆圣华曦药业股份有限公司,重庆401336

出　　处：《西北药学杂志》2022年第1期27-32,共6页Northwest Pharmaceutical Journal

摘　　要：目的建立测定注射用盐酸头孢替安有关物质的高效液相色谱法(high performance liquid chromatography,HPLC)。方法采用NanoChrom ChromCore AQ C_(18)柱(250 mm×4.6 mm,5μm);流动相A[0.05 mol·L^(-1)磷酸二氢钾缓冲液(用0.05 mol·L^(-1)磷酸氢二钠溶液调节pH至4.9)]∶流动相B[0.05 mol·L^(-1)磷酸二氢钾缓冲液(用0.05 mol·L^(-1)磷酸氢二钠溶液调节pH至4.9)-乙腈(80∶20)]梯度洗脱;流速为1.2 mL·min^(-1);柱温为40℃;检测波长为254 nm。结果建立的方法可同时分离注射用盐酸头孢替安中11种有关物质,专属性(各降解条件下,峰纯度均为1)、精密度(RSD<10%)、准确度(平均回收率均>95%)、耐用性(杂质结果偏差均<0.1%)均符合要求。结论该方法操作简便、准确度高、专属性强、灵敏度高,是测定注射用盐酸头孢替安有关物质的有效方法。Objective To establish a high performance liquid chromatography(HPLC)for the determination of related substances in Cefotiam Hydrochloride for Injection.Methods NanoChrom ChromCore AQ C_(18) column(250 mm×4.6 mm,5μm)was used with mobile phase A[0.05 mol·L^(-1) potassium dihydrogen phosphate buffer solution(adjusted with 0.05 mol·L^(-1) sodium hydrogen phosphate to pH 4.9)]:mobile phase B[0.05 mol·L^(-1) potassium dihydrogen phosphate buffer solution(adjusted with 0.05 mol·L^(-1) disodium hydrogen phosphate to pH 4.9)-acetonitrile(80∶20)]by gradient elution.The flow rate was 1.2 mL·min^(-1),the column temperature was 40℃,and the detection wavelength was 254 nm.Results The established method can separate 11 related substances in Cefotiam Hydrochloride for Injection.The specificity(peak purity was 1 under all degradation conditions),precision(RSD<10%),accuracy(average recovery rate>95%)and durability(impurity deviation<0.1%)all met the requirements.Conclusion This method is simple,accurate,specific and sensitive.It is an effective method for the determination of related substances in Cefotiam Hydrochloride for Injection.

关 键 词：注射用盐酸头孢替安 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]