摘要
目的建立高效液相色谱法测定头孢拉定胶囊中的有关物质。方法采用高效液相色谱法。色谱柱为十八烷基硅烷键合硅胶色谱柱(150 mm×4.6 mm,5μm),流动相A为2.72g·L^(-1)磷酸二氢钾(用稀磷酸调节pH值至3.0),流动相B为甲醇,进行梯度洗脱;紫外检测波长为220 nm;柱温为30℃;流速为1.0 mL·min^(-1)。结果头孢拉定胶囊中各杂质峰均分离完全,在相应范围内与峰面积线性关系良好,平均回收率均在93%~108%。结论本方法操作简便,准确度高,适用于头孢拉定胶囊的有关物质测定。
Objective To establish a method for the determination of related substances in cefradine capsules by HPLC.Methods HPLC was performed on a C;column (150 mm×4.6 mm,5μm),with the mobile phase A of 2.72 g·L^(-1)potassium dihydrogen phosphate buffer (adjusting pH to 3.0with phosphoric acid),and mobile phase B of methanol for the linear gradient elution.The detection wavelength was 220 nm.The column temperature was 30℃,and the flow rate was 1.0 mL·min^(-1).Results Each impurity peak in cefradine capsules was completely separated.The calibration curves were linear in their corresponding ranges,and the recoveries of these impurities were between93%-108%.Conclusion This simple,accurate method can be used for the determination of related substances in cefradine capsules.
作者
杜玮炜
DU Wei-wei(Guangzhou Baiyunshan Pharmaceutical Holdings Co.,Ltd.,Baiyunshan Pharmaceutical General Factory,Guangzhou 510515;Guangzhou Baiyunshan Pharmaceutical General Factory/Key Laboratory of Key Technology Research on Chemical Raw Materials and Preparations of Guangdong Province,Guangzhou 510515)
出处
《中南药学》
CAS
2021年第12期2628-2632,共5页
Central South Pharmacy
