HPLC-FLD法测定雌三醇栓中雌三醇的含量  

Content determination of estriol suppository by HPLC-FLD

作　　者：王荪璇 妙苗 王发 邓颖鹏 王嫦鹤 WANG Sun-xuan;MIAO Miao;WANG Fa;DENG Ying-peng;WANG Chang-he(Shaanxi Institute for Food and Drug Control,Xi'an 710065)

机构地区：[1]陕西省食品药品监督检验研究院

出　　处：《中南药学》2019年第12期2139-2141,共3页Central South Pharmacy

基　　金：国家科技重大专项-重大新药创制（No.2017ZX09101001）

摘　　要：目的建立了高效液相色谱-荧光检测器(HPLC-FLD)法测定雌三醇栓中雌三醇含量。方法采用Agilent C18色谱柱(150 mm×4.6 mm,5μm);以乙腈-水(30∶70)为流动相;采用荧光检测器:激发波长为230 nm,发射波长为310 nm;柱温为40℃;流速为2.0 mL·min^-1。结果雌三醇高、中、低3个浓度的平均回收率分别为99.6%、100.2%、99.7%,RSD均≤0.21%(n=3);检测限为2 ng;在1.087~2.709μg·mL^-1与峰面积呈良好的线性关系,线性方程Y=1.2×10^10X+6.4×10^5,r=0.9999(n=5)。结论该方法专属性强、灵敏度高,操作简便、结果准确,能更好地测定雌三醇栓的含量。Objective To determine the content of estriol suppository by HPLC-FLD.Methods HPLC was performed on an Agilent C18(150 mm×4.6 mm,5μm)column.The mobile phase consisted of acetonitrile and water(30∶70).Fluorescence detector was used,with the excited wavelength was 230 nm and the emission wavelength was 310 nm.The column temperature was 40℃.The flow rate was 2.0 mL·min^-1.Results The average recoveries of high,medium and low concentration were 99.6%,100.2%and 99.7%,respectively.The RSD was all≤0.21%(n=3).The limit of detection of estriol was 2 ng,and showed good linearity at 1.087-2.709μg·mL^-1.The linear equation was Y=1.2×10^10 X+6.4×10^5,r=0.9999(n=5).Conclusion The method is specific,sensitive,simple,and accurate,which can be used to determine the content of estriol suppository.

关 键 词：雌三醇 高效液相色谱-荧光检测器 栓剂 含量 

分 类 号：R927[医药卫生—药学]