枸橼酸托法替尼片剂的含量测定  

Determination of Tofacitinib Cirtrate Tablets

作　　者：王娟[1] 邹昕[1] 陈宇翔[1] 江宁宇[1] 郑向阳[1] 陈韋華彬 魏宗有[1] 

机构地区：[1]福建省微生物研究所,福州350007

出　　处：《海峡药学》2017年第2期48-50,共3页Strait Pharmaceutical Journal

基　　金：福建省省属公益类科研院所基本科研专项(2014R1009-2);福建省化药技术重大研发平台(No.2014Y2001);福州市生物制药行业技术创新中心(No.2016-PT-36)

摘　　要：目的建立枸橼酸托法替尼片剂含量测定的方法。方法采用岛津Wonda Cract ODS-2(250×4.65mm,5μm)为色谱柱,柱温30℃,流动相为10m M KH_2PO_4溶液(用NaOH溶液调节pH值为6.8)-乙腈(75∶25),流速为1.0mL·min^(-1),检测波长为210nm。结果托法替尼在0.0374~0.125mg·mL^(-1)浓度范围内呈良好的线性相关(r=0.9998),平均回收率为99.27%,RSD为0.31%。结论本法准确可靠,可用于枸橼酸托法替尼片剂的质量控制。OBJECTIVE To establish a method for determination of tofacitinib cirtrate tablets.METHODS HPLC was carried out on column of Wonda Cract ODS-2（250×4.65 mm,5μm） and column temperature was 30℃.The mobile phase consisited of 10 m M KH_2PO_4 solution（adjust to pH 6.8）-acetonitrile（75∶25） with flow rate of 1.0mL·min（-1）,and the detecting wavelength was at 210 nm.RESULTS The linear range of tofacitinib was 0.03740.125mg·mL（-1）（r=0.9998） and the average recovery was 99.27%,RSD was 0.31%.CONCLUSION This method is reliable and accurate for the quality control of tofacitinib cirtrate tablets.

关 键 词：枸橼酸托法替尼片 托法替尼 HPLC 含量测定 

分 类 号：R927[医药卫生—药学]