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使用曙红荧光分光光度法测定药物制剂和人血浆中的奥氮平和盐酸氟奋乃静:在稳定性研究中的应用

Spectrofluorometric determination of olanzapine and fluphenazine hydrochloride in pharmaceutical preparations and human plasma using eosin: application to stability studies.

作者信息

Belal Fathalla, El-Brashy Amina, El-Enany Nahed, El-Bahay Nihal

机构信息

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

出版信息

J AOAC Int. 2008 Nov-Dec;91(6):1309-17.

PMID:19202791
Abstract

A simple, rapid, and sensitive spectrofluorometric method has been developed for the determination of olanzapine (OLZ) and fluphenazine hydrochloride (FPZ HCI). The proposed method is based on the quantitative quenching effect of the studied drugs on the native fluorescence of eosin at pH 3.4 and 3.2 for OLZ and FPZ HCI, respectively. The fluorescence was measured at 547 nm after excitation at 323 nm. The fluorescence-concentration plots were rectilinear over the range of 0.05-1.0 and 0.10-1.0 microg/mL, with lower detection limits of 1.8 x 10(-3) and 1.2 x 10(-3) microg/mL, for OLZ and FPZ HCI, respectively. The proposed method was successfully applied to the analysis of commercial tablets and ampules containing the drugs, and the results were in good agreement with those obtained with reference methods. The proposed method was further applied to the determination of OLZ in spiked human plasma. The mean recovery was 98.62 +/- 0.24% (n = 4). The method was also used for stability studies of FPZ HCI upon oxidation with hydrogen peroxide, and the kinetics of the reaction were studied. A proposal for the reaction pathway was postulated.

摘要

已开发出一种简单、快速且灵敏的荧光分光光度法用于测定奥氮平(OLZ)和盐酸氟奋乃静(FPZ HCI)。所提出的方法基于所研究药物在pH值分别为3.4(针对OLZ)和3.2(针对FPZ HCI)时对曙红天然荧光的定量猝灭作用。在323nm激发后于547nm处测量荧光。荧光 - 浓度曲线在0.05 - 1.0和0.10 - 1.0μg/mL范围内呈线性,OLZ和FPZ HCI的检测限分别为1.8×10⁻³和1.2×10⁻³μg/mL。所提出的方法成功应用于含这些药物的市售片剂和安瓿的分析,结果与参考方法所得结果高度一致。所提出的方法进一步应用于加标人血浆中OLZ的测定。平均回收率为98.62±0.24%(n = 4)。该方法还用于研究FPZ HCI用过氧化氢氧化时的稳定性,并研究了反应动力学。提出了反应途径的设想。

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