HPLC法测定吡菲尼酮片的含量及有关物质  

Determination of the Content and Related Substances Pirfenidone Tablets and its Related Substances by HPLC

作　　者：刘和凤[1] 高嵩 

机构地区：[1]安徽医科大学附属口腔医院药剂科,合肥230032 [2]合肥信风科技开发有限公司

出　　处：《中国药师》2011年第5期669-671,共3页China Pharmacist

摘　　要：目的:建立HPLC法测定吡菲尼酮片的含量及有关物质。方法:色谱柱为Kromasil C_(18)柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.1 mol·L^(-1)磷酸二氢钾缓冲液(34:66)(氢氧化钠调pH至6.8);流速为1.0 ml·min^(-1);检测波长为220 nm;柱温为30℃。结果:吡菲尼酮在36.00～180.00μg·ml^(-1)浓度范围线性关系良好(r=0.999 9),最低检测限0.72 ng,平均回收率为98.75%,RSD=0.50%,各杂质峰与主峰分离良好。结论:本方法简单方便,专属性强,准确可靠,可用于测定吡菲尼酮片的含量及有关物质。Objective： To establish an HPLC method for the determination of pirfenidone and the related substances in pirfenidone tablets. Method： The analysis was performed on a column of Kromasil C18 （250 mm ×4. 6 mm,5 μm）. The mobile phase consisted of acetonitrile-phosphate buffer （34： 66） （NaOH adjusting pH to 6. 8 ）. The flow rate was 1.0 ml· min ^-1. The detection wavelength was set at 220 nm. The column temperature was 30 ℃. Result： Good linearity was obtained over the range of 36. 00-180. 00 μg·ml^-1 for pirfenidone （r = 0. 999 9）. The limit of detection was 0. 72 ng. The average recovery was 98.75% （RSD = 0. 50% ）. A good separation for pirfenidone and the related substances was achieved. Conclusion： The method is simple,sensitive and accurate,and can be used in the quality control for pirfenidone tablets.

关 键 词：高效液相色谱 吡菲尼酮 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]