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-C_(18)(4.6 mm×250 mm,5μm),磷酸二氢铵溶液(pH3.5)-乙腈(3∶5)为流动相,检测波长为310 nm,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20~200μg·mL^(-1)内线性关系良好(r=0.999 9,n=6),且重复性好(RSD=0.129%,n=6);平均回收率98.6%(RSD=1.2%,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。
Objective：To establish a test method for assay of Gliquidone Tablets by HPLC. Methods：The analysis was performed in Ultimate XB-C18 （4. 6 mm ×250 ram,5 μm） with ammonium dihydrogen phosphate buffer so- lution-acetonitrile（3：5 ） as the mobile phase. The detection wavelength was set as 310 nm and mobile phase was used as the diluent. Results：Gliquidone and Isoquinoline peaks were separated very well. It was shown the good linearity existing between the peak areas and concentration of gliquidone in the range of 20 - 200 μg·mL^-1 （ r = 0. 999 9, n = 6 ） with the good repeatability （ RSD = 0. 129%, n = 6 ） and average recovery as 98.6% （RSD = 1.2%, n =6）. Conclusion： The HPLC method has the good sensitivity, accuracy and precision and it can be used for quality control of gliquidone tablets. This method can be referred to improve the specification of Gliquidone Tablets.
出处
《中国药品标准》
CAS
2017年第4期279-282,共4页
Drug Standards of China
