奈韦拉平_____奈韦拉平；有关物质；含量；高效液相色谱法

HPLC法测定奈韦拉平片的含量及有关物质

http://www.100md.com 《广东药学院学报》 2004年第5期

奈韦拉平,,奈韦拉平；有关物质；含量；高效液相色谱法,1实验部分,3讨论,参考文献

     摘要目的高效液相色谱法测定奈韦拉平片的含量及有关物质的研究。方法采用C18色谱柱(5 μm,4.6 mm×250 mm)。以ψ(乙腈∶水)=23∶77为流动相，流速1.0 mL/min,紫外检测器于214 nm测定。结果 HPLC法的线性范围为0.5~125 μg/mL,r=0.9999,最低检测限2 ng,样品溶液在8 h内稳定，日内精密度和日间精密度良好(RSD<0.5%),回收率为99.6%。结论采用HPLC法测定奈韦拉平片的含量及有关物质的方法简便，结果准确可靠。

    关键词奈韦拉平；有关物质；含量；高效液相色谱法

    中图号 R927.2 文章编号:1006-8783(2004)05-0488-03 文献标识码:A

    HPLC determination of nevirapine tablets and its related substances

    LAI Hongning, FENG Yuhuan, LIANG Songqing

    (1.Ranbaxy Limited Guangzhou, Guangdong, Guangzhou 510380;

    2.Guangdong College of Pharmacy,Guangzhou, Guangdong 510240)

    Abstract Objective To determine the content and relate substances of nevirapine by HPLC. Methods HPLC method was developed for the determination of nevirapine that was separated on a C18 column (5 μm, 4.6 mm×250 mm) with the mobile phase of acetonitrilewater (23∶77). Results The flow rate was 1.0 mL/min and detected at 214 nm. The standard curve was linear in the range of 0.5~125 μg/mL and the correlation coefficient was 0.9999, the least detective range is 2 ng, the sample solution is stable within 8 h, and the intraday precision and the interday precision are good (RSD<0.5%). The recovery results are 99.6%. Conclusion The method to determine the content and relate substances of nevirapine by HPLC is easy to operate and the assaying results are accurate. ......

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