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高效液相色谱法测定伏格列波糖口腔速溶膜中伏格列波糖的含量和有关物质

作者:孙文霞, 陈 勇     时间:2019-09-29 14:54      浏览:265
文章编号:1004-5422(2019)03-0247-04                                           DOI:10.3969/j.issn.1004-5422.2019.03.004


高效液相色谱法测定伏格列波糖口腔速溶膜中伏格列波糖的含量和有关物质


孙文霞, 陈 勇

(成都大学 四川抗菌素工业研究所, 四川 成都 610052)

摘 要: 建立测定伏格列波糖口腔速溶膜剂中伏格列波糖含量及其有关物质的高效液相色谱法.采用柱后衍生HPLC荧光检测法,采用亲水C18色谱柱,流动相为0.045%辛烷磺酸钠的磷酸盐缓冲液—甲醇(94∶6),荧光检测器激发波长为350 nm,发射波长为430 nm,柱温为25 ℃,流动相与荧光试剂流速相同,进样量为100 μL.结果显示,伏格列波糖与各个杂质峰分离较好,在25.0~50.0 μg/mL范围内,伏格列波糖浓度与峰面积的线性关系良好(R=0.9999),高、中、低3种浓度的加样回收率为98.81%~101.58%,RSD为0.99%~1.27% ,检测限和定量限分别为2 ng和10 ng.实验表明,所建立的方法准确可靠、专属性强,适用于伏格列波糖口腔速溶膜剂的质量控制.
关键词: 伏格列波糖;口腔速溶膜剂;含量测定;有关物质

中图分类号:R927.2;O657.72          文献标志码:A


Determination of Contents and Related Substances in Voglibose Oral Fast Dissolving

 Films by HPLC

SUN Wenxia, CHEN Yong
(Sichuan Industrial Institute of Antibiotics, Chengdu University, Chengdu 610052, China)


Abstract:The paper is going to establish an HPLC for the determination of both contents and related substances of voglibose in voglibose oral fast dissolving films.Post-column derivatization fluorescence method was used in the experiment.The analysis was performed on a C18 column with 0045% sodium octanesulfonate phosphate buffer solution methanol(94∶6) as mobile phase.The effluents were detected by fluoescence detector with an excitation wave length of 350 nm,an emission wave length of 430 nm and a column temperature of 25 ℃.The flow rate of the fluorescent reagents was the same as that of the mobile phase.And the injection volume was 100 μL.The results show that the linear relationship between the voglibose concentration and peak area is good(R=0.9999) within the range of 25.0~50.0 μg/mL for voglibose.The average recovery rates are from 98.81% to 101.58% for three different levels of voglibose,RSD is from 0.99% to 1.27%.The quantitation limit and detection limit is 2 ng and 10 ng,respectively.This method is accurate,specific,and suitable for the quality control of voglibose oral fast dissolving films.
Key words:voglibose;oral fast dissolving films;content determination;related substances