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采用一阶导数同步荧光光谱法快速同时测定制剂和加标血浆中的愈创甘油醚和福可定。

Fast concurrent determination of guaifenesin and pholcodine in formulations and spiked plasma using first derivative synchronous spectrofluorimetric approach.

机构信息

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta, Egypt.

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

出版信息

Luminescence. 2024 Jan;39(1):e4660. doi: 10.1002/bio.4660.

DOI:10.1002/bio.4660
PMID:38286595
Abstract

Guaifenesin and pholcodine are frequently co-formulated in certain dosage forms. A new fast first derivative synchronous spectrofluorometric method has been used for their simultaneous analysis in mixtures. Here, first derivative synchronous spectrofluorometry enabled the successful simultaneous estimation of guaifenesin at 283 nm and pholcodine at 275 nm using a wavelength difference (Δλ) of 40 nm. The method was fully validated following International Council of Harmonization guidelines. For guaifenesin and pholcodine, linearity was determined within the corresponding ranges of 0.05-0.30 and 0.10-6.0 μg/ml. The two drugs were effectively analyzed using the developed approach in their respective formulations, and the results showed good agreement with those attained using reference methods. The method demonstrated excellent sensitivity, with detection limits down to 0.007 and 0.030 μg/ml and quantitation limits of 0.020 and 0.010 μg/ml for guaifenesin and pholcodine, respectively. Therefore, the procedure was successful in determining these drugs simultaneously in vitro in spiked plasma samples and syrup dosage form. The developed methodology also offered an environmentally friendly advantage by utilizing water as the optimal diluting solvent throughout the whole work. Different greenness approaches were investigated to ensure the method's ecofriendly properties.

摘要

愈创甘油醚和福尔可定常以一定剂量形式共同配制。本文采用新的快速一阶导数同步荧光光谱法用于混合物中二者的同时分析。在此,一阶导数同步荧光光谱法使同时估算愈创甘油醚在 283nm 和福尔可定在 275nm 成为可能,波长差(Δλ)为 40nm。该方法完全按照国际协调理事会的指导原则进行了验证。对于愈创甘油醚和福尔可定,线性范围分别为 0.05-0.30 和 0.10-6.0μg/ml。采用所开发的方法可有效地分析各自制剂中的两种药物,结果与参考方法获得的结果吻合良好。该方法具有出色的灵敏度,检测限低至 0.007 和 0.030μg/ml,定量限分别为 0.020 和 0.010μg/ml。因此,该程序成功地实现了在体外血浆样品和糖浆制剂中同时测定这些药物。所开发的方法还具有环保优势,因为在整个工作过程中均使用水作为最佳稀释溶剂。研究了不同的绿色化方法以确保该方法的环保特性。

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