糠酸莫米松乳膏有关物质的测定及杂质的确定  

Determination of Related Substances in Mometasone Furoate Cream and Determination of Impurities

作　　者：王松 袁文才 肖梦杰 

机构地区：[1]湖北省食品药品监督管理局技术审评核查中心,湖北武汉430071 [2]武汉诺安药业有限公司,湖北武汉430070 [3]宜昌妇幼保健医院,湖北宜昌443000

出　　处：《亚太传统医药》2017年第19期29-33,共5页Asia-Pacific Traditional Medicine

摘　　要：目的:建立HPLC法测定糠酸莫米松乳膏有关物质并对其杂质进行初步确定。方法:采用ZORBAX Eclipse XDB-C_(18)(4.6mm×100mm,3.5μm)色谱柱,以水(A)-乙腈(B)为流动相,梯度洗脱,检测波长254nm,柱温30℃,进样量为50μL,流速2.0mL/min。结果:糠酸莫米松与各杂质、各杂质之间的分离度均良好,糠酸莫米松在0.2~10.0μg/mL浓度范围内与峰面积呈良好的线性关系,回归方程为Y=40.264 6 X+14.742 6(r^2=0.999 8)。结论:此方法能准确定量,可用于糠酸莫米松乳膏的质量控制,并确定了4个特定已知杂质C、D、G和H,其相对保留时间分别为0.88、0.94、0.73和0.56。Objective：To establish a HPLC method for the determination of related substances of Mometasone Furoate Cream and its impurities were determined preliminarily. Methods： ZORBAX Eclipse XDB-C18 （4.6 mm × 100 mm, 3.5μm）column was adopted. Water as mobile phase A, acetonitrile as mobile phase B, gradient elution, The detection wavelength was 254nm. The flow rate was 2.0 mL · min^-1 , and the column temperature was 30℃. Results： Mometasone Furoate was well separate from impurity. The calibration curves was linear in range of 0.2 -10μg · mL^-1 for Mometasone Furoate , The regression equation is Y=40. 264 6X＋ 14. 742 6 （r^2= 0.9998）. Conclusion. This method can be quantitatively quantified and can be used for the quality control of Mometasone Furoate Cream and the relative retention times of four specific known impurities C, D, G and H are 0.88, 0.94, 0.73 and 0. 56, respectively.

关 键 词：糠酸莫米松乳膏 HPLC 糠酸莫米松 有关物质 

分 类 号：R284.2[医药卫生—中药学]