摘要
目的 建立高效液相色谱-串联质谱法检测富马酸替诺福韦艾拉酚胺中L-丙氨酸异丙酯的含量。方法 色谱柱为ACE Excel 3 C18-AR(4.6 mm×150 mm,3 μm),流动相为0.1%甲酸溶液(A)-乙腈(B),按程序进行梯度洗脱,离子源为ESI源,以正离子、多重反应监测模式进行检测。结果 L-丙氨酸异丙酯在0.06~1.19 μg·mL^(-1)与峰面积线性关系良好,回收率在102.3%~108.3%,检测限为0.02 μg·mL^(-1),定量限为0.06 μg·mL^(-1)。结论 该方法专属性强,灵敏度高,适用于富马酸替诺福韦艾拉酚胺中L-丙氨酸异丙酯的测定。
Objective To determine L-alanine isopropyl ester in tenofovir alafenamide fumarate by LC-MS.Methods ACE Excel 3 C18-AR column (4.6 mm×150 mm,3 μm) was used,with gradient elution of 0.1% formic acid solution and acetonitrile as mobile phase.The analytes were detected in an ESI under positive ion mode with multip reaction monitoring.Results The linear range was 0.06-1.19 μg·mL^(-1),the recovery between 102.3%-108.3%,the LOD was 0.02 μg·mL^(-1),and the LOQ was 0.06 μg·mL^(-1).Conclusion The method is specific and sensitive,and can be used for the determination of L-alanine isopropyl ester in tenofovir alafenamide fumarate.
作者
李昌亮
尚金凤
廖正华
蔡立荣
易必新
马晓宁
LI Chang-liang;SHANG Jin-feng;LIAO Zheng-hua;CAI Li-rong;YI Bi-xin;MA Xiao-ning(Hunan Institute for Drug Control,Changsha 410001;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001;Hinye Pharmaceutical Co.,Ltd,Changsha 410331)
出处
《中南药学》
CAS
2022年第10期2399-2402,共4页
Central South Pharmacy
基金
湖南省科技厅科药联合基金(No.2021JJ80032)。
作者简介
李昌亮,男,主任药师,主要从事药品质量控制与标准研究工作,email:21405563@qq.com;通信作者:马晓宁,女,副主任药师,主要从事药品质量控制与标准研究工作,email:5967120@qq.com。
