HPLC法测定伏立康唑眼用凝胶中有关物质的含量  

Determination of related substances in voriconazole eye gel by HPLC

作　　者：李琳[1] 刘家鑫[1] 龙猜 赵冬梅 赵云丽[1] 于治国[1] LI Lin;LIU Jiaxin;LONG Cai;ZHAO Dongmei;ZHAO Yunli;YU Zhiguo(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2018年第7期557-562,586,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立RP-HPLC法测定伏立康唑眼用凝胶中4种有关物质的含量。方法以伏立康唑为参照物,测定其有关物质(A、B、C和D)的相对保留时间和相对校正因子,同时用校正因子法和外标法测定4种有关物质含量,为验证方法的准确性,对2种方法测定的结果进行比较。结果有关物质(A、B、C和D)相对于主成分伏立康唑的相对保留时间分别为0.73、0.66、0.61和0.78;相对校正因子分别为1.10、0.50、0.38和1.37,校正因子法与外标法测定的结果无显著性差异。结论加校正因子的主成分自身对照法能够准确测定伏立康唑眼用凝胶中4种有关物质的含量。Objective To establish a RP-HPLC method for the determination of 4 related substances in voriconazole eye gel. Methods The relative retention times（ RRTs） and the relative correction factors（ RCFs）of the related substances（ A,B,C,and D） were determined using voriconazole as the internal standard; the contents of the related substances were quantified with the method using RCFs and the external standard method（ ESM）,and the results obtained were compared to verify the method accuracy. Results To voriconazole,the RRTs of related substances（ A,B,C and D） were 0. 73,0. 66,0. 61 and 0. 78,and their RCFs were 1. 10,0. 50,0. 38 and 1. 37,respectively. There was no significant difference in the results between the method using RCFs and ESM. Conclusion The RP-HPLC method using RCFs can be applied to determine the related substances in voriconazole eye gel.

关 键 词：伏立康唑眼用凝胶 有关物质 校正因子 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]