HPLC法测定立他司特原料药中的有关物质  

Determination of the Related Substances in Lifitegrast Bulk Drugs by HPLC

作　　者：李亚苹 杨江涛 林丽娅 张福利[2] 何永富 LI Yaping;YANG Jiangtao;LIN Liya;ZHANG Fuli;HE Yongfu(School of Chemistry and Chemical Engineering,Shanghai University of Engineering and Science,Shanghai 201620;Shanghai Institute of Pharmaceutical Industry Co.,Ltd.,Shanghai 201203;Zhejiang Boxiao Biopharmaceutical Co.,Ltd.,Hangzhou 310014)

机构地区：[1]上海工程技术大学化学化工学院,上海201620 [2]上海医药工业研究院有限公司,上海201203 [3]浙江博崤生物制药有限公司,浙江杭州310014

出　　处：《中国医药工业杂志》2024年第11期1565-1571,共7页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法测定立他司特(1)原料药中的有关物质。采用Fortis Diphenyl色谱柱(4.6 mm×250 mm,5μm),以10 mmol/L磷酸二氢钾溶液和乙腈(95∶5)为流动相A,以乙腈为流动相B,梯度洗脱。流速为1.0 mL/min,柱温为40℃,检测波长为205 nm,进样量为5μL。结果显示,1与各杂质间的分离度均大于1.5,并在相应浓度范围内线性关系良好。平均回收率(n=9)为99.3%~104.1%,RSD均≤5.1%。该方法操作简单,结果准确,适用于1原料药中有关物质的测定。An HPLC method was established to determine the related substances in lifitegrast(1)bulk drugs.The Fortis Diphenyl column(4.6 mm×250 mm,5μm)was used,and the analysis was carried out in the gradient elution mode with the mixture of 10 mmol/L potassium dihydrogen phosphate solution and acetonitrile in a volume ratio of 95∶5 as mobile phase A,and acetonitrile as mobile phase B.The flow rate was 1.0 mL/min,the column temperature was 40℃,the detection wavelength was 205 nm,and the injection volume was 5μL.The results showed that the separation degree between 1 and each related substance was greater than 1.5,and it was linear for 1 and the related substances in the corresponding concentration ranges.The average recoveries(n=9)of 1 and the related substances were 99.3%-104.1%,and the RSDs were all less than 5.1%.The established method is easy to operate,accurate in results,which is suitable for the determination of relevant substances in 1 bulk drugs.

关 键 词：立他司特 高效液相色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学] R988.1[医药卫生—药学]