反相高效液相色谱法测定格列喹酮片含量.doc

反相高效液相色谱法测定格列喹酮片含量
于海云,刘晶晶,王红红(内蒙古通辽市食品药品检验所,通辽02800)
摘要目的:建立降糖类药物格列喹酮片的反相高效液相色谱含量测定方法。方法:应用反相高效液相色谱法进行测定,色谱柱为Ultimate® XB-C18(×250mm,5μm),流动相磷酸二氢铵溶液()-乙腈(3:5)为流动相,检测波长为310nm,流动相为稀释剂。结果:格列喹酮与其他杂质峰异喹啉物分离度良好,格列喹酮在20μg·mL-1~200μg·mL-1 内线性关系良好(r=,n=6),且重复性好(RSD=%,n=6); %(RSD=%,n=6)。结论:反相高效液相色谱法测定格列喹酮片的含量专属性强,准确度和精密度良好,可以用于该药物的分析与质量控制,为完善与提升格列喹酮片的质量标准提供依据。
关键词:格列喹酮;反相高效液相色谱法;含量
中图分类号:R 文献表示码:A 文章编号:1009-3656(2017)-4-
Determination of the Content for Gliquidone Tablets by High Performance Liquid Chromatography
YU Haiyun,LIU Jingjing,Wang Honghong(Tongliao Institute for Drug and Food Control , Tongliao 028000,China)
Abstract Objective:To establish a method for the quantitative of Gliquidone Tablets by HPLC. Method:The analysis was performed by using a C18 column with a mobile phase of ammonium-dihydrogen phosphate-acetonitrile buffer solution(3:5). The detection wavelength was310 nm for Gliquidone Tablets,mobile phase was used as diluent. Results: Gliquidone and Isoquinoline was separated very well from each other, good linearity of the proposed method was shown in the range of 20μg·mL-1~200μg·mL-1 (r = ,n=6) ,and hadbetter repeatability (RSD=%, n=6);the average recovery of the method was %(RSD =%,n=6). Conclusion:The results of the experiments showed that it is a high sensitivity, accuracy method with good precision . The