HPLC法测定双氯芬酸钾片有关物质的探讨  

Determination of Related Substances in Diclofenac Potassium Tablets by HPLC

作　　者：石晶萍[1] 赵沈娟[1] 

机构地区：[1]扬子江药业集团质量管理部,江苏225321

出　　处：《中国药品标准》2009年第1期50-52,共3页Drug Standards of China

摘　　要：目的:探讨影响HPLC法测定双氯芬酸钾片有关物质的因素。方法:将双氯芬酸钾片在不同的试验条件下分别用水、甲醇两种溶剂溶解后测量有关物质。结果:双氯芬酸钾片水溶液光稳定性差,有关物质随光照时间增加而升高;双氯芬酸钾片甲醇溶液光稳定性好。结论:现行药品标准中双氯芬酸钾片中有关物质测定方法不合理,须进行修订。Objecitve： Study on determination of related substances in Diclofenac Potassium Tablets by HPLC. Method ： Comparing the contents of related substances of Diclofenac Potassium Tablets in water and methanol. Results：Diclofenac Potassium Tablets is not stable in water, the content of related substances increase with the light time, methanol solution is more stable. Conclusion ： The method of the state drug specification to determinate related substances of Diclofenac Potassium Tablets in water solution is unreasonable and should be adjusted.

关 键 词：HPLC 双氯芬酸钾片 有关物质 

分 类 号：R971.1[医药卫生—药品] R286.0[医药卫生—药学]