HPLC法测定盐酸特比萘芬阴道用凝胶的含量  

Determination of the content of terbinafinc hydrochloridg gel for vagina by HPLC

作　　者：陈丽娜[1] 

机构地区：[1]深圳市宝安区人民医院,广东深圳518101

出　　处：《湖北中医学院学报》2009年第5期29-30,共2页Journal of Hubei College of Traditional Chinese Medicine

摘　　要：目的建立用HPLC法测定盐酸特比萘芬阴道用凝胶中盐酸特比萘芬含量的方法。方法Hypersil ODS2柱;检测波长:280nm;流动相:四氢呋喃-乙腈-四甲基氢氧化铵缓冲液(取10%四甲基氢氧化铵14.5mL,加水800mL,用0.7mol/L磷酸溶液调pH值至7.8,加水稀释至1000mL)=15∶60∶25;柱温:25℃;流速:1.0mL/m in;进样量:20μL。结果线性范围为121.08μg/mL-282.52μg/mL(r=0.9998,n=5);精密度试验的RSD为0.35%;回收率为100.3%,RSD为0.31%;测定3批自制样品含量均在90.0%-110.0%之间。结论本法简单、快速、精确、重复性高,可作为产品的质量控制方法。Objective:To establish an HPLC method for the determination of terbinafinc hydrochloride in gel for vagina.Methods:The analytical column was Hypersil ODS(5μm,4.6×150mm),the mobile phase was composed of tetrahydofuran,acetonitrile and tetramethylammonium hydroxide(10% tetramethylammonium hydroxide 14.5mL in 1000mL water and adjusted to pH 7.8 with 0.7mol·L-1phosphoric acid)(15:60:25,v/v/v)with the flow rate of 1.0mL·min-1,the detection wavelength was 280nm and column temperature was 25℃.External standard method was used.Results:The Calibration curve was linear within the concentration range of 121.08-282.52μg·mL-1(r=0.9998,n=5).The average recovery of terbinafinc hydrochloride gel for vagina was 100.3%(RSD=0.31%,n=9).Conclusion:The method is simple,rapid and accurate with good repetitiveness,therefore can be applied to quality control.

关 键 词：盐酸特比萘芬 高效液相色谱法 阴道给药 凝胶剂 含量测定 

分 类 号：R927.2[医药卫生—药学]