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用于测定药物制剂和人体血浆中费乐地平与尼莫地平的荧光分光光度法和胶束增敏荧光分光光度法。

Spectrofluorimetric and micelle-enhanced spectrofluorimetric methods for determination of Felodipine and Nimodipine in pharmaceutical preparations and human plasma.

作者信息

Mohamed Abdel-Maaboud I, Omar Mahmoud A, Hammad Mohamed A, Mohamed Abobakr A

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Assiut University, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2015;149:934-40. doi: 10.1016/j.saa.2015.05.026. Epub 2015 May 19.

Abstract

Rapid, simple and sensitive two spectrofluorimetric methods have been developed for determination of Felodipine (FLD) and Nimodipine (NDP). The first method is based on measuring the native fluorescence of either Felodipine or Nimodipine at 426 nm after excitation at 385 nm. The fluorescence intensity-concentration plots of Felodipine and Nimodipine were rectilinear over the concentration ranges (0.2-3.0) and (0.5-4.0) μg ml(-1), respectively. The second method is based on measuring the fluorescence intensity of the studied drugs in micellar media (0.3% Tween-80) at λex=385 nm and λem=423 nm. In the presence of 0.3% Tween-80, about 1.6-fold and 2.1-fold enhancement can be achieved in the relative fluorescence intensity (RFI) of Felodipine and Nimodipine, respectively. The fluorescence intensity-concentration plots of Felodipine and Nimodipine with Tween-80 were rectilinear over the concentration ranges (0.05-4.0) and (0.1-4.0) μg ml(-1), respectively with determination coefficients (r(2)) of 0.9981 and 0.9990, and limit of quantitation of 0.05 and 0.027μg ml(-1) for FLD and NDP, respectively. The proposed methods were validated according to ICH guidelines and have been successfully applied to the analysis of these drugs in their commercial tablets with high accuracy (97.6-98.8±0.50-1.42%, n=5). The high sensitivity of micellar method permits its application for determination of the cited drugs in spiked human plasma with % recovery (91.9-106.6±0.66-1.7%, n=6).

摘要

已开发出两种快速、简便且灵敏的荧光分光光度法用于测定非洛地平(FLD)和尼莫地平(NDP)。第一种方法基于在385nm激发后,测量非洛地平或尼莫地平在426nm处的天然荧光。非洛地平和尼莫地平的荧光强度-浓度曲线在浓度范围(0.2 - 3.0)和(0.5 - 4.0)μg ml⁻¹内分别呈线性。第二种方法基于在λex = 385nm和λem = 423nm处测量所研究药物在胶束介质(0.3%吐温-80)中的荧光强度。在存在0.3%吐温-80的情况下,非洛地平和尼莫地平的相对荧光强度(RFI)分别可提高约1.6倍和2.1倍。非洛地平和尼莫地平与吐温-80的荧光强度-浓度曲线在浓度范围(0.05 - 4.0)和(0.1 - 4.0)μg ml⁻¹内分别呈线性,非洛地平和尼莫地平的测定系数(r²)分别为0.9981和0.9990,定量限分别为0.05和0.027μg ml⁻¹。所提出的方法根据ICH指南进行了验证,并已成功应用于其市售片剂中这些药物的分析,准确度高(97.6 - 98.8±0.50 - 1.42%,n = 5)。胶束法的高灵敏度使其可用于加标人血浆中上述药物的测定,回收率为(91.9 - 106.6±0.66 - 1.7%,n = 6)。

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