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同时测定药物制剂中罗格列酮和二甲双胍的柱高效液相色谱法

Column high-performance liquid chromatographic method for the simultaneous determination of rosiglitazone and metformin in a pharmaceutical preparation.

作者信息

Ali Azzam R, Duraidi Ibrahim I, Saket Munib M, Abu-Nameh Eyad S M

机构信息

Research and Development, Mid Pharma, Amman, Jordan.

出版信息

J AOAC Int. 2009 Jan-Feb;92(1):119-24.

Abstract

An efficient, sensitive, and simple method was developed for the simultaneous determination of rosiglitazone and metformin hydrochloride in a combination tablet dosage form by column high-performance liquid chromatography. The mobile phase used was ammonium dihydrogen phosphate adjusted to pH 5.25 with sodium hydroxide. The limits of detection and quantitation were in the range of 0.5-1.6 microg/mL, respectively, for metformin hydrochloride, and 0.00201-0.0067 microg/mL, respectively, for rosiglitazone. The linearity was studied in the concentration range of 0.12-0.31 microg/mL for rosiglitazone and 30.6-76.7 microg/mL for metformin hydrochloride. The recovered amounts of metformin hydrochloride and rosiglitazone were 100-103.8 and 101-103.7%, respectively.

摘要

建立了一种高效、灵敏且简便的柱高效液相色谱法,用于同时测定复方片剂剂型中罗格列酮和盐酸二甲双胍的含量。所用流动相为用氢氧化钠调节至pH 5.25的磷酸二氢铵。盐酸二甲双胍的检测限和定量限分别在0.5 - 1.6微克/毫升范围内,罗格列酮的检测限和定量限分别在0.00201 - 0.0067微克/毫升范围内。罗格列酮在0.12 - 0.31微克/毫升浓度范围内以及盐酸二甲双胍在30.6 - 76.7微克/毫升浓度范围内进行线性研究。盐酸二甲双胍和罗格列酮的回收率分别为100 - 103.8%和101 - 103.7%。

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