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剂型中乙磺半胱氨酸的动力学分光光度法测定

Kinetic spectrophotometric determination of ethamsylate in dosage forms.

作者信息

El-Enany Nahed, Belal Fathalla, Rizk Mohamed

机构信息

University of Mansoura, Faculty of Pharmacy, Department of Analytical Chemistry, 35516, Mansoura, Egypt.

出版信息

J AOAC Int. 2007 May-Jun;90(3):679-85.

PMID:17580619
Abstract

A simple and sensitive kinetic method has been developed for the determination of ethamsylate (ESL) in its pharmaceutical preparations. The method is based upon oxidation of ESL with 3-methyl-2-benzothiazolinone hydrazone hydrochloride in presence of cerium (IV) ammonium sulfate at room temperature for 20 min. The absorbance of the reaction product is measured at 514 nm. The absorbance-concentration plot was rectilinear over the range of 4-30 microg/mL (r = 0.9999). The lower detection limit was 0.267 microl/mL (9.110 x 10(-6) M) and the lower quantitation limit was 0.808 microg/mL. The different experimental parameters affecting the development and stability of the reaction product were studied and optimized. The proposed method was applied to the determination of ESL in formulations, and the results obtained were in good agreement with those obtained using a reference method. The proposed method was also used for the in vitro detection of ESL in spiked human plasma at its therapeutic concentration level.

摘要

已开发出一种简单灵敏的动力学方法用于测定其药物制剂中的酚磺乙胺(ESL)。该方法基于在室温下,在硫酸铈(IV)铵存在下,酚磺乙胺与盐酸3-甲基-2-苯并噻唑啉酮腙反应20分钟。在514nm处测量反应产物的吸光度。吸光度-浓度曲线在4-30μg/mL范围内呈线性(r = 0.9999)。最低检测限为0.267μg/mL(9.110×10⁻⁶M),最低定量限为0.808μg/mL。研究并优化了影响反应产物生成和稳定性的不同实验参数。该方法应用于制剂中酚磺乙胺的测定,所得结果与参考方法的结果高度一致。该方法还用于在治疗浓度水平下加标的人血浆中酚磺乙胺的体外检测。

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引用本文的文献

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A new and simple HPLC method for determination of etamsylate in human plasma and its application to pharmacokinetic study in healthy adult male volunteers.一种新的、简单的 HPLC 法测定人血浆中甲磺酸乙酯及其在健康成年男性志愿者体内药代动力学研究中的应用。
Saudi Pharm J. 2013 Oct;21(4):405-10. doi: 10.1016/j.jsps.2012.12.001.
2
Conventional and first derivative synchronous fluorometric determination of ethamsylate in pharmaceutical preparations and biological fluids. Application to stability studies.常规和一阶导数同步荧光法测定药物制剂和生物体液中的氨甲环酸。应用于稳定性研究。
J Fluoresc. 2011 Jul;21(4):1371-84. doi: 10.1007/s10895-010-0819-6. Epub 2011 Feb 24.