摘要
目的:建立测定利克飞龙原料有关物质的HPLC方法。方法:色谱柱为Kromasil C_(18)(250 mm×4.6 mm,5μm);流动相为甲醇-0.05%磷酸(85:15);检测波长为226 am;流速为0.9 ml·min^(-1);柱温为25℃;进样量为10μl。结果:各杂质峰与主峰分离度良好,检出限及定量限分别为0.20 ng及0.59 ng。结论:该方法灵敏度高、精密度好、专属性强,可用于利克飞龙原料有关物质的测定。
Objective： To establish a determination method for the related substances in the raw material of licofelone by HPLC. Methods： A Kromasil C 18 （250 mm×4.6 mm,5 μm） column was adopted with a mobile phase consisting of methanol-0.05% phos- phate （85：15 ） , the flow rate was 0.9 ml ·min^-1, the detection wavelength was set at 226nm, the column temperature was 25℃ and the injection volume was 10 μl. Results： The resolutions of the related substances were acceptable. The detection limit and the quanti- tation limit of the samples were 0.20ng and 0.59ng, respectively. Conclusion： The method is sensitive, accurate and specific, and can be used to determine the related substances in the raw material of licofelone.
出处
《中国药师》
CAS
2014年第1期56-58,共3页
China Pharmacist
