摘要
目的建立吲哚美辛片含量及有关物质的测定方法。方法采用HPLC法,乙腈-0.1mol.L-1冰醋酸(55∶45)为流动相;流速为1.0mL.mi-n1;检测波长为228nm。结果在该色谱条件下,吲哚美辛与有关物质分离良好;吲哚美辛在20.192～504.800μg.mL-1范围内呈良好的线性关系(r=1.0000);平均回收率为99.96%,RSD=1.26%(n=6)。结论该方法简便、重复性好,可用于本品的含量测定及有关物质检查。
Objective To establish a method for the determination of indometacin tablets and its related substances.Methods The separation was performed on HPLC.The mobile phase was acetonitrile-0.1mol·L-1 glacial acetic acid solution（55∶45）at a flow rate of 1.0mL·min-1.The detection wavelength was at 228nm.Results The related substances were completely separated from indometacin.The linear range of 20.192~504.800μg·mL-1（r=1.0000） was obtained.The average recovery was 99.96% and RSD was 1.26%（n=6）.Conclusion This method is convenient and reproducible.It can be used for the determination of indometacin and its related substances in indometacin tablets.
出处
《中国药事》
CAS
2012年第2期172-174,177,共4页
Chinese Pharmaceutical Affairs
