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在多种剂型和加标人血浆中绿藜芦醛对愈创木酚甘油醚的高灵敏和选择性光谱检测。

Green highly sensitive and selective spectroscopic detection of guaifenesin in multiple dosage forms and spiked human plasma.

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Abbassia, 11566, Cairo, Egypt.

出版信息

Sci Rep. 2024 Aug 12;14(1):18694. doi: 10.1038/s41598-024-68711-1.

Abstract

Guaifenesin (GUA) is determined in dosage forms and plasma using two methods. The spectrofluorimetric technique relies on the measurement of native fluorescence intensity at 302 nm upon excitation wavelength "223 nm". The method was validated according to ICH and FDA guidelines. A concentration range of 0.1-1.1 μg/mL was used, with limit of detection (LOD) and quantification (LOQ) values 0.03 and 0.08 µg/mL, respectively. This method was used to measure GUA in tablets and plasma, with %recovery of 100.44% ± 0.037 and 101.03% ± 0.751. Furthermore, multivariate chemometric-assisted spectrophotometric methods are used for the determination of GUA, paracetamol (PARA), oxomemazine (OXO), and sodium benzoate (SB) in their lab mixtures. The concentration ranges of 2.0-10.0, 4.0-16.0, 2.0-10.0, and 3.0-10.0 µg/mL for OXO, GUA, PARA, and SB; respectively, were used. LOD and LOQ were 0.33, 0.68, 0.28, and 0.29 µg/mL, and 1.00, 2.06, 0.84, and 0.87 µg/mL for PARA, GUA, OXO, and SB. For the suppository application, the partial least square (PLS) model was used with %recovery 98.49% ± 0.5, 98.51% ± 0.64, 100.21% ± 0.36 & 98.13% ± 0.51, although the multivariate curve resolution alternating least-squares (MCR-ALS) model was used with %recovery 101.39 ± 0.45, 99.19 ± 0.2, 100.24 ± 0.12, and 98.61 ± 0.32 for OXO, GUA, PARA, and SB. Analytical Eco-scale and Analytical Greenness Assessment were used to assess the greenness level of our techniques.

摘要

瓜菲那辛(GUA)在剂型和血浆中使用两种方法进行测定。荧光分光光度技术依赖于在激发波长“223nm”下测量 302nm 处的本征荧光强度。该方法根据 ICH 和 FDA 指南进行了验证。使用了 0.1-1.1μg/mL 的浓度范围,检测限(LOD)和定量限(LOQ)值分别为 0.03 和 0.08μg/mL。该方法用于测定片剂和血浆中的 GUA,回收率为 100.44%±0.037 和 101.03%±0.751。此外,多元化学计量分光光度法用于测定其混合实验室中的 GUA、对乙酰氨基酚(PARA)、奥洛他定(OXO)和苯甲酸钠(SB)。OXO、GUA、PARA 和 SB 的浓度范围分别为 2.0-10.0、4.0-16.0、2.0-10.0 和 3.0-10.0μg/mL。LOD 和 LOQ 分别为 0.33、0.68、0.28 和 0.29μg/mL,以及 1.00、2.06、0.84 和 0.87μg/mL,用于 PARA、GUA、OXO 和 SB。对于栓剂应用,使用偏最小二乘法(PLS)模型,回收率为 98.49%±0.5、98.51%±0.64、100.21%±0.36 和 98.13%±0.51,尽管使用多元曲线分辨交替最小二乘法(MCR-ALS)模型,回收率为 101.39%±0.45、99.19%±0.2、100.24%±0.12 和 98.61%±0.32,用于 OXO、GUA、PARA 和 SB。使用分析生态规模和分析绿色度评估来评估我们技术的绿色度水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8885/11319457/ae887886baf5/41598_2024_68711_Fig1_HTML.jpg

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