摘要
建立高效液相色谱法测定罗格列酮钠片含量及有关物质。该法采用ZorbaxSB-C18色谱柱(4.6mm×250mm,5μm),流动相为0.1mol/L乙酸钠溶液(用稀乙酸调节至pH5.5)-甲醇(30∶70),流速1mL·min-1,检测波长为245nm。在进样量(0.4~4.8)μg时,与峰面积呈良好线性,r=0.9999(n=7),平均回收率100.1%,日内和日间RSD分别为0.56%及0.63%(n=9)。有关物质可得到很好分离。该法简便、准确、专属。
To determine the content and its related substances of Rosiglitazone Sodium tablets by HPLC the Zorbax SB-C18 column (4.6 mm×250 mm, 5 μm)was used, 0.1 mol·L^-1 sodium acetate solution (adjusted to pH 5.5 with acetate): methanol (30:70) as the mobile phase, at a flow rate of 1 mL·min^-1, at detection wavelength 245 nm. The linearity of peak area was good when the injected quantity of Rosiglitazone sodium was in the range of (0.4-4.8) μg(r=0.999 9, n=7). The recovery of this method was 100.1%, the intra-day RSD and inter-day RSD were 0.56% and 0.63%(n=9) respectively. The related substance can be separated as well. It is conclused this method is convenient, accurate and specific.
出处
《科学技术与工程》
2006年第12期1678-1680,共3页
Science Technology and Engineering