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优化和验证了药物制剂中美托咪定、吡拉西坦和左乙拉西坦的流动注射分光光度分析方法。

Optimized and validated flow-injection spectrophotometric analysis of topiramate, piracetam and levetiracetam in pharmaceutical formulations.

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, University of Suez Canal, Ismailia 41522, Egypt.

出版信息

Acta Pharm. 2011 Dec;61(4):377-89. doi: 10.2478/v10007-011-0038-y.

Abstract

Application of a sensitive and rapid flow injection analysis (FIA) method for determination of topiramate, piracetam, and levetiracetam in pharmaceutical formulations has been investigated. The method is based on the reaction with ortho-phtalaldehyde and 2-mercaptoethanol in a basic buffer and measurement of absorbance at 295 nm under flow conditions. Variables affecting the determination such as sample injection volume, pH, ionic strength, reagent concentrations, flow rate of reagent and other FIA parameters were optimized to produce the most sensitive and reproducible results using a quarter-fraction factorial design, for five factors at two levels. Also, the method has been optimized and fully validated in terms of linearity and range, limit of detection and quantitation, precision, selectivity and accuracy. The method was successfully applied to the analysis of pharmaceutical preparations.

摘要

应用灵敏快速的流动注射分析(FIA)方法测定药物制剂中的托吡酯、吡拉西坦和左乙拉西坦。该方法基于在碱性缓冲液中与邻苯二醛和 2-巯基乙醇的反应,并在流动条件下测量 295nm 处的吸光度。使用四分位部分因析设计,对五个二水平因素的样品进样体积、pH 值、离子强度、试剂浓度、试剂流速和其他 FIA 参数等影响测定的变量进行了优化,以获得最灵敏和重现性的结果。该方法在线性和范围、检测限和定量限、精密度、选择性和准确性方面进行了优化和充分验证。该方法成功应用于药物制剂的分析。

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