HPLC法测定双氯芬酸钠缓释片的有关物质  

Determination of Related Substances in Diclofenac Sodium Sustained Release Tablets by HPLC

作　　者：刘丽芳[1] 冯金元[1] 

机构地区：[1]广州市药品检验所,510160

出　　处：《中国药品标准》2007年第1期39-41,共3页Drug Standards of China

摘　　要：目的:应用高效液相色谱法测定双氯芬酸钠缓释片中有关物质。方法:色谱条件:C8柱,甲醇-磷酸盐缓冲液(0.01mol/L磷酸和0.01mol/L)磷酸二氢钠等量混合,用氢氧化钠试液调pH值至3.0)(6∶4)为流动相,检测波长为254nm.结果:该方法双氯芬酸钠的检测限为4.5×10-4μg;进样的精密度RSD为1.7%。结论:本法简便、灵敏、准确。Objective：To establish an HPLC method for determination of related substances in Diclofenac Sodium Sustained Release Tablets. Methods .. The HPLC was carried out with C8 column and mobile phase composed of methanol-phosphate buffer solution （pH 3.0） （6 ： 4）. The detection wavelength was 254nm. Results ：The detection limit is 4. 5×10^-4μg and the relative standard deviation for replicate injection is 1.7%. Conclusion：This method is simple,sensitive and accurate.

关 键 词：高效液相色谱法 双氯芬酸钠缓释片 有关物质 

分 类 号：R921.2[医药卫生—药学]