HPLC__(期刊论文)

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

http://www.100md.com 《广东药学院学报》 2004年第6期

HPLC,,HPLC；肠溶片；双氯芬酸钠；含量测定；有关物质,1试药与仪器,2含量测定,3有关物质的检查,4讨论,参考文献

     摘要目的用HPLC法同时测定双氯芬酸钠肠溶片(OLFEN50)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∶55∶35)为流动相；流速为1.0 mL/min；检测波长为245 nm。结果双氯芬酸钠在40.571～202.856 μg/mL范围内与峰面积呈现线性良好，回收率为100.9%，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、快捷。

    关键词 HPLC；肠溶片；双氯芬酸钠；含量测定；有关物质

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

    HE Yulan, ZHANG Lirong,XIAO jian

    (Guangzhou Inst. Drug Control, Guangzhou 510160,China)

    Abstract Objective Determination of diclofenac sodium in diclofenac sodium entericcoated tablets and the related substances by HPLC. Methods C18 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. ......

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