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摘 要:目的:建立尼尔雌醇含量测定的HPLC方法。方法:以InertsilODS-3和HYPERSILODS为固定相,甲醇-水(80∶20)为流动相,在检测波长221nm的条件下分离测定尼尔雌醇,并对方法进行了认证。结果:在建立的色谱条件下,尼尔雌醇与其杂质能完全分离,在浓度20.08~200.8μg·mL-1范围内线性关系良好,相关系数为0.9999。结论:本法准确、方便、可靠。
Development of HPLC Determination of Nilestriol ZHANG Xin-yun(Shanghai
Institute for Drug Control,200233) Abstract:Objective:To develop a HPLC method for determination of nilestriol.Methods:Chromatographic condition was,column:C18;mobile phase:methanol-water (80∶20),detection wavelength:221 nm.Two types of column,Inertsil ODS-3 and HYPERSIL ODS,and products produced in the acidic solution,basic solution,H2O2 solution or by being exposed to light were used to validate this method.Results:Under the described chromatogaphic condition nilestriol was completely separated from its impurities.The relationship between response and the concentration in the range of 20.08~200.8 μg.mL-1 is linear,the correlation coefficent is 0.999 9.Conclusion:This method is accurate,convenient and reliable.
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作者单位:张欣耘(上海市药品检验所 200233) 李建华(上海市药品检验所 200233) 杨永健(上海市药品检验所 200233) 参考文献: [1]ChP(中国药典).1995.Vol
Ⅱ(二部):192 收稿日期:2000年1月17日 出版日期:2001年3月31日 |
原载于《药物分析杂志》2001 Vol.21 No.2 P.105-107
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