HPLC法测定非诺洛芬钙胶囊的含量和有关物质  

HPLC determination of fenoprofen calcium capsules and its related substances

作　　者：吴颖[1] 刘茜[1] 陈桂良[1] 乐健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《药物分析杂志》2009年第1期66-69,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立同时测定非诺洛芬钙胶囊含量及有关物质的HPLC方法。方法:采用Agilent1100型高效液相色谱仪,色谱柱为Kromasil C8(4.6mm×250mm,5μm)柱,流动相为乙腈-水-磷酸(50:49.6:0.4),流速1.0mL.min-1,检测波长272nm,柱温30℃,进样量20μL。结果:非诺洛芬的进样浓度在0.1524～152.4μg.mL-1范围内,与峰面积呈良好的线性关系,r=0.9999;A、B两厂家产品的平均回收率(n=9)分别为100.2%和101.0%;热分解产物能从主峰中分离,测得非诺洛芬的最小检出量为0.91ng。结论:本方法准确、灵敏、可靠,专属性强,可用于非诺洛芬钙制剂的质量控制。Objective ： To establish an HPLC method for the analysis of fenoprofen calcium capsules and its related substances. Methods：The HPLC method was performed on an Agilent 1100 liquid chromatography. Kromasil Cs column （ 4. 6 mm × 250 mm, 5 μm ） was adopted with the mobile phase of acetonitrile - water - phosphoric acid （50： 49.6： 0. 4）. The flow rate was 1.0 mL · min^-1 and the detection wavelength was set at 272 nm. The column temperature was set at 30 ℃ and the injection volume was 20 μL. Results：A linearity between peak area and feno- profen concentration was achieved in the range of 0. 1524 -152. 4 μg · mL^-1 with r of 0. 9999. The average recoveries（n = 9） of products of A and B company were 100. 2% and 101.0%, respectively. The heated degradation substances could be separated from main peak. The lowest detectable amount was 0. 91 ng. Conclusion： The method is accurate, specific, sensitive and can be used for quality control of fenoprofen calcium preparation.

关 键 词：非诺洛芬 含量测定 有关物质 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]