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pingyijian

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[交流] 急求(已找到,谢谢):哪位手头有《药物分析杂志》08年第6期?

哪位手头有《药物分析杂志》08年第6期?
帮忙看一下有没有一篇测定盐酸苯乙双胍有关物质的文章?

[ Last edited by pingyijian on 2008-8-18 at 21:12 ]
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wu9820168

铁杆木虫 (正式写手)

★ ★
pingyijian(金币+2,VIP+0):THANKS
高效液相色谱法测定盐酸苯乙双胍的有关物质

王本晓,朱海燕,丁洁

(山东省医药工业研究所,济南 250100)



摘要  目的:建立高效液相色谱法测定盐酸苯乙双胍的有关物质。方法:采用Phenomenex-ODS-C18色谱柱(250 mm×4.60 mm,5 μm);以甲醇-5 mmol·L-1磷酸二氢钾溶液(含有10 mmol·L-1十二烷基磺酸钠,用磷酸调节pH至3.5±0.05)(72∶28)为流动相;流速1.0 mL·min-1;检测波长216 nm;柱温:室温。结果:盐酸苯乙双胍的线性范围为3~300 μg·mL-1,r=0.9999,检测限为0.5 ng,精密度为0.4%;双氰胺的线性范围为0.05~0.3 μg·mL-1,r=0.9999,检测限为0.15 ng,精密度为0.6%。结论:本方法简便可靠,灵敏度高,重现性好,可用于盐酸苯乙双胍的质量控制。

关键词:盐酸苯乙双胍;高效液相色谱法;有关物质

中图分类号:R917      文献标识码:A      文章编号:0254-1793(2008)06-0967-03



HPLC determination of the related substances of phenformin hydrochloride

WANG Ben-xiao,ZHU Hai-yan,DING Jie

(Shandong Institute of Pharmaceutical Industry,Jinan,250100)



Abstract  Objective:To establish an HPLC method for determination of the related substances of phenformin hydrochloride.Methods:The separation was performed on a Phenomenex-ODS-C18column(250 mm×4.60 mm,5 μm).The mobile phase was composed of methanol-10 mmol·L-1sodium dodecylsufonate in 5 mmol·L-1 potassium dihydrogen phosphate (previously adjusted to pH 3.5±0.05 with phosphoric acid)(72∶28).The flow rate was 1.0 mL·min-1.The detection was carried out with a diode array detector at 216 nm.Column temperature was at room temperature.Results:The calibration curve of phenformin hydrochloride was linear between 3 to 300 μg·mL-1 (r=0.9999),the detection limit was 0.5 ng with RSD of 0.4%(n=6);The calibration curve of dicyandiamide was linear between 0.05-0.3 μg·mL-1(r=0.9999),the detection limit was 0.15 ng with RSD of 0.6%(n=6).Conclusion:The method is simple and accurate with good sensitivity and reproducibility.It can be used for the quality control of phenformin hydrochloride.

Key words:phenformin hydrochloride;HPLC;related substances


http://www.nicpbp.org.cn/cmsweb/webportal/W361/A2337.html
2楼2008-08-18 10:03:21
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pingyijian

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多谢!!
我想看的是是否已出版

[ Last edited by pingyijian on 2008-8-18 at 10:09 ]
3楼2008-08-18 10:07:20
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