RP-HPLC法检查利克飞龙片中的有关物质

Determination of Related Substances in Licofelone Tablets by RP-HPLC

目的：建立利克飞龙片中有关物质的检查方法。方法：采用反相高效液相色谱法。色谱柱为Kromasil C18,流动相为乙腈-0．05％磷酸水溶液（60：40，V／V），流速为1．0ml／min，检测波长为222nm，柱温为25℃，进样量为10μl；采用主成分自身对照法计算总杂质量。结果：主峰与相邻峰的分离度良好，利克飞龙检测质量浓度线性范围为8．1-162μg／ml（r=0．9999），检测限及定量限分别为0．25、0．89ng；3批样品总杂质量≤0．31％。结论：建立的方法灵敏度高、精密度好、专属性强，可用于利克飞龙片中有关物质的检查。

OBJECTIVE： To establish the method for the determination of the related substances in Licofelone tablets. METHODS： RP-HPLC method was adopted. The determination was performed on Kromasil C18 column with mobile phase consisted of acetonitrile-0.05% phosphate solution （60 ： 40, V/V） at the flow rate of 1.0 ml/min; the detection wavelength was set at 222 nm and column temperature was 25 ℃. The injection volume was 10μl. The total impurities was calculated by main component self contrast method. RESULTS： The main peak was well-separated from the adjacent peak. The linear range of licofelone were 8.1-162 μg/ml （r=0.999 9）. The detection limit and quantitation limit were 0.25 ng and 0.89 ng, respectively. Total contents of impurities were lower than 0.31% in 3 batches of samples. CONCLUSIONS： The method is sensitive, precise and specific, and can be used to determine the related substances in Licofelone tablets.