摘要
目的：建立双氯芬酸钠注射液含量测定的高效液相色谱方法。方法：采用Ultimate LP-C18-H色谱柱（5μm,4.6 mm×250 mm）,甲醇-4%冰醋酸溶液（70∶30）为流动相,流速为1.0 mL/min,柱温30℃,检测波长为276 nm,采用外标法进行定量。结果：双氯芬酸钠的线性范围为5.03-503.40μg/m L,回归方程为Area=20.942×Amt1-54.805（n=5）,相关系数大于0.999。从高（120%）、中（100%）和低（80%）3个添加水平的检测结果可以看出,双氯芬酸钠的回收率为98.17%-103.21%。结论：本方法可用于测定双氯芬酸钠注射液中双氯芬酸钠的含量。
Objective：A HPLC method has been developed to determine the content of diclofenac sodium in diclofenac sodium injection. Methods：A Ultimate LP-C18-H column（5 μm,4.6 mm ×250 mm） was used with the mobile phase of methanol-4% acetic acid solution（70 ∶30） at the detection wavelength of 276 nm with a flow rate of 1.0 m L/min. Results：The quantification was carried out by the external standard method and the linear range of diclofenac sodium was between5.03～629.00 μg/m L. And the regression equation was Area=20.942×Amt1-54.805（n=5） with the correlation to be more than0.999. The average recoveries at three different levels of 120%,100% and 80% of the sample ranged between 98.17% and103.21%. Conclusions：HPLC method could be used for the determination of diclofenac sodium injection.
作者
郭玉凡
陈长青
李攀
周衡
邓俊
陈盟
GUO Yufan;CHEN Changqing;LI Pan;ZHOU Heng;DENG Jun;CHEN Meng(Zhengzhou Bairui Animal Pharmaceutical CO, LTD., Zhengzhou Henan 450000, Chin)
出处
《中兽医医药杂志》
2018年第3期54-57,共4页
Journal of Traditional Chinese Veterinary Medicine
基金
郑州市2016年度科技重大专项(项目编号:162PZD ZX190)
