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利用 native 和 synchronous 荧光光谱法测定阿伐那非在其共配方药物(盐酸达泊西汀)存在下的含量:在药物制剂、生物体液和含量均匀度中的应用。

Native and synchronous fluorescence spectroscopy for determination of avanafil in presence of its co-formulated drug (dapoxetine hydrochloride): Application to pharmaceutical product, biological fluid and content uniformity.

机构信息

Pharmaceutical Chemistry Department, National Organization for Drug Control and Research (NODCAR), P.O. Box 29, Giza, Egypt.

Pharmaceutical Chemistry Department, National Organization for Drug Control and Research (NODCAR), P.O. Box 29, Giza, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2020 Mar 15;229:117898. doi: 10.1016/j.saa.2019.117898. Epub 2019 Dec 18.

DOI:10.1016/j.saa.2019.117898
PMID:31901802
Abstract

The native and synchronous fluorescence spectroscopy procedures have been established and validated for the simultaneous determination of a binary mixture of dapoxetine hydrochloride (DAP) and avanafil (AVA). The first procedure is based on measurement of native fluorescence intensity of both drugs at λ 337 nm and 370 nm using λ 290 nm and 314 nm for DAP and AVA in methanol respectively. The second procedure describes a measurement of synchronous fluorescence intensity of these drugs at 232 nm for DAP, and 267 nm for AVA, using Δλ of 90nm. In the first procedure the fluorescence concentration were 0.1-4.0 μg/mL for DAP and 0.5-16 μg/mL for AVA. For the second procedure fluorescence concentrations were 0.025-1.0 μg/mL and 0.5-16 μg/mL for DAP and AVA respectively, with lower detection limit and quantification limits. The processes were successfully used for the limitation of DAP and AVA in their drug product without pre-separation. Then, the techniques were utilized for the determination of DAP and AVA in biological fluids. There is a good agreement between these results and the results obtained using a reference method.

摘要

已经建立并验证了原生和同步荧光光谱法,用于同时测定盐酸达泊西汀(DAP)和阿伐那非(AVA)的二元混合物。第一个程序是基于在甲醇中分别使用λ 290 nm 和 314 nm 测量两种药物的原生荧光强度,在λ 337 nm 和 370 nm 处测量 DAP 和 AVA 的原生荧光强度。第二个程序描述了在 232 nm 处测量 DAP 的同步荧光强度,在 267 nm 处测量 AVA 的同步荧光强度,使用Δλ为 90nm。在第一个程序中,DAP 的荧光浓度为 0.1-4.0μg/mL,AVA 的荧光浓度为 0.5-16μg/mL。对于第二个程序,DAP 和 AVA 的荧光浓度分别为 0.025-1.0μg/mL 和 0.5-16μg/mL,具有更低的检测限和定量限。这些过程成功地用于在没有预分离的情况下限制药物产品中的 DAP 和 AVA。然后,该技术用于测定生物流体中的 DAP 和 AVA。这些结果与使用参考方法获得的结果非常吻合。

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