HPLC法同时测定双氯芬酸钠肠溶片中双氯芬酸钠的含量及有关物质

Determination of diclofenac sodium in diclofenac sodium enteric-coated tablets and the related substances by HPLC

目的用HPLC法同时测定双氯芬酸钠肠溶片 (OLFEN 5 0 )中双氯芬酸钠的含量及有关物质。方法以十八烷基硅烷键合硅胶为填充剂 ;以 ψ[乙腈∶甲醇∶磷酸二氢钾缓冲液 (用 ρ =85 %磷酸调节pH至 2 .5 ) ]=(10∶5 5∶35 )为流动相 ;流速为 1.0mL/min ;检测波长为 2 4 5nm。结果双氯芬酸钠在 4 0 .5 71～ 2 0 2 .85 6 μg/mL范围内与峰面积呈现线性良好 ,回收率为 10 0 .9% ,样品的有关物质分离完全。结论本法结果准确 ,分离效果好 ,重现性良好 ,方法简便。

Objective Determination of diclofenac sodium in diclofenac sodium enteric-coated tablets and the related substances by HPLC. Methods C 18 column was used, with acetonitrile-methanol-potassium dihydrogen phosphate (adjusted the solution with phosphoric acid (85%) to pH 2.5) (10∶55∶35) as mobile phase; the flow rate was 1.0 mL/min; detected at 245 nm. Results Within 40.571～202.856 μg/mL. Diclofenac Sodium had a good linearity(r=0.99998). The average recovery was 100.9%, with the RSD of 0.64%(n=5). Conclusions The related substances of sample separate completely.It prove to be a simple,accurate,rapid and sensitive method.