摘要
目的建立高效液相色谱法测定替戈拉生原料药中3种有关物质的含量。方法采用Agilent Proshell 120 EC-C18色谱柱(4.6 mm×100 mm,2.7μm);流动相A为0.01 mol·L^(-1)醋酸铵缓冲液,流动相B为乙腈,线性梯度洗脱;检测波长为220 nm;流速为0.7 mL·min^(-1);柱温为40℃;进样量为10μL。结果杂质A~C的线性范围分别为0.0972~1.944μg·mL^(-1)(r=0.9999)、0.0509~1.018μg·mL^(-1)(r=0.9997)及0.1089~2.178μg·mL^(-1)(r=0.9997),平均回收率分别为96.27%、95.40%和96.10%,RSD分别为2.1%、2.3%和2.2%。结论该方法准确可靠,灵敏度高,可用于替戈拉生原料药有关物质的控制。
Objective To determine the 3 related substances in tegoprazan by HPLC.Methods An Agilent Proshell 120 EC-C18(4.6 mm×100 mm,2.7μm)column was used.The mobile phase A was 0.01 mol·L^(-1)ammonium acetate buffer,and the mobile phase B was acetonitrile,with linear gradient elution.The detection wavelength was 220 nm.The flow rate was 0.7 mL·min^(-1),and the column temperature was 40℃.The injection volume was 10μL.Results The calibration curves of impurity A,B and C were 0.0972~1.944μg·mL^(-1)(r=0.9999),0.0509~1.018μg·mL^(-1)(r=0.9997),and 0.1089~2.178μg·mL^(-1)(r=0.9997).The average recovery was 96.27%,95.40%and 96.10%,with RSDs of 2.1%,2.3%and 2.2%.Conclusion The method is accurate and reliable,which can be used for the quality control of tegoprazan.
作者
张磊
苑艳飞
林小晖
王丽华
徐树娟
申应德
ZHANG Lei;YUAN Yan-fei;LIN Xiao-hui;WANG Li-hua;XU Shu-juan;SHEN Ying-de(Linyi Inspection and Testing Center,Linyi Shandong 276001;Tai’an Institute for Food and Drug Control,Tai’an Shandong 271000;Jinan Institute for Food and Drug Control,Jinan 250000)
出处
《中南药学》
CAS
2024年第7期1899-1902,共4页
Central South Pharmacy
