摘要
建立高效液相色谱-示差折光检测法测定伏格列波糖口腔崩解片中伏格列波糖的含量。采用Hy-persil ODS2 C18柱,用十八烷基硅烷键合硅胶为填充剂,柱温40℃,0.045%辛烷磺酸钠的磷酸盐缓冲液(pH3.5)为流动相,流速为1.0mL.min^-1。伏格列波糖在0.0505-0.2525mg.mL^-1范围内线性关系良好,r=0.9991,平均回收率为100.8%,RSD=0.1%。本方法准确、重复性好,可用于该片剂的质量控制。
An RID-HPLC method was developed to determine the content of voglibose sodium in Voglibose Orally Disintegrating Tablets. Using ODS column, the temperature of column was set at 40℃. The mobile phase was 0. 045 % sodium 1-octanesulfonate phosphoric buffer (pH 3.5) with the flow rate of 1.0 mL.min^-1. The linear of voglibose was in the ranges of 0. 1067-0. 5335mg.mL^-1, r=0. 9991. The average recovery was 100.8G , RSD= 0. 1%. The method is accurate, reproducible and can be used for quality control.
出处
《中国药事》
CAS
2008年第12期1093-1094,1130,共3页
Chinese Pharmaceutical Affairs