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引用本文:石云峰,李会林,林丽琴.HPLC测定炔雌醚含量和有关物质[J].中国现代应用药学,2013,30(1):95-98.
SHI Yunfeng,LI Huilin,LIN Liqin.Determination of Quinestrol and Its Related Substances by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(1):95-98.
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HPLC测定炔雌醚含量和有关物质
石云峰1, 李会林1, 林丽琴2
1.浙江省食品药品检验研究院,杭州 310004;2.杭州市药品检验所,杭州 310017
摘要:
目的 建立HPLC测定炔雌醚含量和有关物质的方法。方法 采用C18柱,以甲醇-水(90∶10)为流动相;流速为1.0 mL·min-1;检测波长为279 nm。结果 炔雌醚的线性范围为0.078 8~0.788 4 mg·mL-1(r=1.000 0),平均回收率为99.9%,RSD为0.80%(n=9),炔雌醚检测限浓度为0.06 mg·mL-1。结论 该方法简便、准确、专属性强,可作为产品质量检测方法。
关键词:  炔雌醚  高效液相色谱法  有关物质
DOI:
分类号:
基金项目:
Determination of Quinestrol and Its Related Substances by HPLC
SHI Yunfeng1, LI Huilin2, LIN Liqin2
1.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;2.Hangzhou Institute for Drug Control, Hangzhou 310017, China
Abstract:
OBJECTIVE To establish an HPLC method for content determination of quinestrol and its related substances. METHODS A C18 column was used with the mobile phase of water-methanol(90∶10). The flow rate was 1.0 mL·min-1, and the detection wavelength was 279 nm. RESULTS The calibration curve of quinestrol was linear in the range of 0.078 8-0.788 4 mg·mL-1(r=1.000 0), and the average recovery was 99.9%, RSD was 0.80%(n=9). The detection limit of quinestrol was 0.06 μg·mL-1. CONCLUSION The method is rapid, accurate and reliable for content determination of quinestrol and related substances.
Key words:  quinestrol  HPLC  related substance
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