杨世华1,王秀萍2，杨春丽3
（1.湖北省荆门市药品检验所448000，2.华中科技大学同济医学院梨园医院,3.湖北百科药业股份有限公司,448000）
摘要 目的：建立测定惠妥滋含量及相关物质的高效液相色谱法。方法：采用Aglient CLC-ODS 色谱柱，乙酸铵缓冲液：甲醇=85：15为流动相，流速为1.0ml/min ，检测波长：254nm 。结果：惠妥滋在14-25ug/ml浓度范围内，惠妥滋与其浓度呈良好的线性关系，r=0.9991。重现性试验RSD0.3%(n=6)，方法回收率为100.2%。结论：方法可靠，简单可行。
关健词: 惠妥滋 ;高效液相色谱法;
Determination of the Content of Didanosine by HPLC
Yang Shihua1, Wang Xiuping2, Yang Chunli3 (1.Hubei Institute for Drug control, Jingmen 448000; 2 Liyuan Hospital，Tongji Medical college of Huazhong University of Science and Technology, Hubei, Wuhan 430000; 3.Hubei Biocause Pharmaceutical Co, Ltd, Jingmen, 448000,P.R.China)
ABSTRACT Objective: To set up a method for determining the content of didanosine and the related substances by HPLC. Method: Aglient CLC –ODS column was used. The ammonium acetate buffer solution–methanol (85:15) as mobile phase. The flow rate was 1.0 ml·min-1. The detection wavelength was 254nm. Result: The calibration curve presented a good linear within the range of 14 to 25ug·ml-1(r=0.9991). The average recovery was 100.2 %( RSD=0.3 %(n=6)). Conclusion: This method is accurate and reliable.
KEY WORDS HPLC; Didanosine 资料来自:中国药师-专业站 |