王军,张晓明,曾万溪
WANG Jun,ZHANG Xiao-ming,ZENG Wan-xi (Skypharm Tech Co.

• 1:珠海天翼医药技术开发有限公司
• 2:珠海天翼医药技术开发有限公司
• 3:珠海天翼医药技术开发有限公司 广东珠海519080
• 4:广东珠海519080

摘要(Abstract)：

目的建立一种快速简便的测定盐酸多西环素的高效液相色谱法。方法采用反相高效液相色谱法和C18色谱柱,以0.05mol/L草酸铵溶液-二甲基甲酰铵-0.2mol/L磷酸氢二铵-甲醇(50∶36∶4∶10)为流动相,检测波长为280nm,流速为0.9ml/min,柱温35℃。结果盐酸多西环素保留时间10min左右;在2.5~250μg/ml的浓度内r=0.9999(n=8)线性关系良好;日内以及日间的RSD分别为0.79%、0.73%;回收率为98.0%(RSD为1.04%)。结论该法可以快速,准确地测定盐酸多西环素的含量及有关物质,回收率高,分离度好,比中国药典2005版该品种项下的色谱条件及系统适应性强。
Objective To develop a rapid and simple HPLC method for determination of Doxycycline hydrochloride. Method RP-High-pressure liquid chromatography was performed on a C_ 18 column with mobile phase of 0.05 mol/L diammonium oxalate—N,N-dimethylformamide—0.2 mol/L diammonium hydrogen phosphate-methanol(50∶36∶4∶10).The monitoring wavelength was 280 nm. The flow-rate was 0.9 ml/min. The column temperature was 35 ℃. Result The retain time of Doxycycline Hyciate was about 10 min. Good linearity between peak area and concentration was found in the range of 2.5~250 μg/ml for Doxycycline Hyciate. The day-in and day-out RSD were 0.79% and 0.73% respectively. The mean recovery was 98.0% (RSD was 1.04%). Conclusion This modified HPLC method is more sensitive, specific and accurate than the condition of ChP. 2005 for assay Doxycycline Hyciate and its relative substances.

关键词(KeyWords)： 高效液相色谱法;盐酸多西环素;有关物质
HPLC; Doxycycline Hyciate: relative substances

Abstract:

Keywords:

基金项目(Foundation): 珠海市科技创新基金资助[珠高技财(2005)5号]

作者(Author): 王军,张晓明,曾万溪
WANG Jun,ZHANG Xiao-ming,ZENG Wan-xi (Skypharm Tech Co.

参考文献(References)：

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