HPLC法测定萘普生缓释片有关物质的含量

Determination of Related Substances by high performance liquid chromatography in Naproxen Sustained release Tablets

目的:建立以高效液相色谱法测定萘普生缓释片有关物质含量的方法。方法:采用高效液相色谱法(HPLC)法;色谱柱:以十八烷基硅烷键合硅胶为填充剂;以0.05mol/L的磷酸二氢钾-甲醇-乙腈(40:25:35)磷酸调节PH至3.0为流动相;检测波长为240nm;流速:1.0ml/min;进样量:10μl。结果:萘普生和6-甲氧基-2-萘乙酮的检测限分别为0.103ng和0.168ng,供试品中主峰与各杂质峰之间,已知杂质(6-甲氧基-2-萘乙酮)与其他杂质峰之间分离度均大于1.5。结论:本法简单、专属性强,能有效控制产品质量。

Objectlve：To establish the method of related substance determination in Naproxen sustained release tablets by high performance liquid chromatography. Methods：The article is to use high performance liquid chromatography. The ehromato baruses oetadecyl bonded silica as bulking agent and 0. 05mol/L potassium all- hydrogen phosphate - methyl alcohol - acetonitrile （40：25：35 ） whose power of hydrogen is adjusted to 3.0 as mobile phase ; detecting wave length is 240nm and flow rating is 1.0ml/min ; the sample size is 10 μl. Results： The limits of quantitation of Naproxen and 6 - methoxyl - 2 - acetonaphthone are respectively 0. 103ng and 0. 168ng. The resolving power of 6 - methoxyl -2 - acetonaphthonc exceeds that of other impurity among the main peak and other impurity peak in the sample. Concinsinus：This method is convenient and its specificity is strong. It can efficiently control the produvt quality.