梯度洗脱高效液相色谱法测定萘丁美酮的含量及其有关物质检查

目的 :建立测定萘丁美酮的HPLC方法 ,并进行萘丁美酮含量测定和有关物质检查。方法 :Agilent 110 0型高效液相色谱仪 ,色谱柱为AgilentZorbaxC 18(15 0mm× 4 .6mm ,5 μm ) ,流动相采用梯度洗脱。UV检测波长为 2 5 4nm。结果 :本法测定萘丁美酮的线性相关系数为 0 .9999;日内、日间精密度均小于 1% ,方法回收率高、中、低 3点分别为 99.4 0 % ,10 1.6 0 %和 97.11%。结论 :本方法测定萘丁美酮 ,专属性强 ,灵敏度高 ,重现性好

Assay of nabumetone and its related substances examination by gradient elution HPLC method

AIM: To establish a HPLC method for the content determination of nabumetone and measure its related substances. METHODS: Agilent 1100 series HPLC system was applied with the column, Agilent Zorbax C-18 (4.6 mm×150 mm,5 μm). Gradient elution was applied. UV detector was set at 254 nm. RESULTS: The relative coefficient of the linearity of this method for determination of nabumetone was 0.9999; the recovery rates of high, middle and low concentration were 99.40%, 101.60% and 97.11%, respectively. The RSD of intra-day and inter-day were all less than 1 %. CONCLUSION: The results verify that the method is rapid, sensitive and reproductive. Determination of nabumetone is also accurate. All of the nabumetone determined in this assay are complied with the requirements of European pharmacopoeia 2001.