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通过与铁(III)离子形成络合物,用分光光度法测定药物制剂中的阿仑膦酸盐。

Spectrophotometric determination of alendronate in pharmaceutical formulations via complex formation with Fe(III) ions.

作者信息

Kuljanin Jadranka, Janković Ivana, Nedeljković Jovan, Prstojević Dusica, Marinković Valentina

机构信息

Laboratory for Radiation Chemistry and Physics, Vinca Institute of Nuclear Sciences, Belgrade, Yugoslavia.

出版信息

J Pharm Biomed Anal. 2002 Jun 15;28(6):1215-20. doi: 10.1016/s0731-7085(02)00021-3.

Abstract

The formation of the complex between alendronate, non-chromophoric bisphosphonate drug important for the treatment of a variety of bone diseases, and iron(III) chloride in perchloric acid solution was studied. The stoichiometric ratio of alendronate to Fe(III) ions in the chromophoric complex was determined to be 1:1. The conditional stability constant was logK'(ave)=4.50(SD=0.15), indicating that the Fe(III)-alendronate complex is a complex of medium stability. The optimum conditions for this reaction were ascertained and a spectrophotometric method was developed for the determination of alendronate in the concentration range 8.1-162.5 microg ml(-1), the detection limit being 2 microg ml(-1). The method was validated for the direct determination of alendronate in tablet dosage formulations.

摘要

研究了阿仑膦酸钠(一种对多种骨疾病治疗很重要的非发色双膦酸盐药物)与高氯酸溶液中的氯化铁(III)形成络合物的情况。测定了发色络合物中阿仑膦酸钠与铁(III)离子的化学计量比为1:1。条件稳定常数为logK'(ave)=4.50(标准差=0.15),表明铁(III)-阿仑膦酸钠络合物是一种中等稳定性的络合物。确定了该反应的最佳条件,并建立了一种分光光度法,用于测定浓度范围为8.1 - 162.5微克/毫升的阿仑膦酸钠,检测限为2微克/毫升。该方法经验证可直接测定片剂剂型中的阿仑膦酸钠。

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