格列美脲含量测定方法的改进

目的改进格列美脲原料含量测定的方法。方法采用高效液相色谱法,Agilent Zorbax SB-C18色谱柱(4.6 mm×250 mm,5μm),以磷酸二氢钠溶液(取0.5 g磷酸二氢钠,加水500 mL溶解,用磷酸调pH至2.5)-乙腈(500∶500)为流动相,流速1.0 mL·min-1,检测波长为228 nm。结果系统适用性符合要求,格列美脲的定量限为0.1 ng,在87.92¹ 318.80 ng范围内线性关系良好(r=1.000 0)。平均回收率为100.3%,RSD为0.8%(n=9)。结论建立的方法准确、灵敏,可代替滴定法用于格列美脲的含量测定。

Improvement of the assay method of glimepiride

Objective To improve the determine method for glimepiride. Methods The determination was performed on an Agilent Zorbax SB - Cls column（4. 6 mm × 250 mm,5μm） , and the mobile phase consisted of 500 mL sodium dihydrogen phosphate solution （ dissolve 0. 5 g of sodium dihydrogen phosphate in 500 mL of water and adjust to pH 2. 5 with phosphoric acid） and 500 mL of acetonitrileat the flow rate 1.0 mL· min-1. The detection wavelenth was 228nm. Results The system suitability met the requirements. The LOQs of glimepiride was 0. 1 ng. The linearity was found in the rang of 87. 92 - 1 318. 80 ng（ r = 1. 000 0 ）. The corresponding average recovery was 100. 3% with RSD 0. 8% （n = 9 ）. Conclusion The method was sensitive and accurate, and suitable for the assay of glimepirede.