El Gamal Rania, El Abass Samah Abo, Elmansi Heba M
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam Bin-Abdul Aziz University, PO Box 173, Al-Kharj 11942, Kingdom of Saudi Arabia.
R Soc Open Sci. 2020 Dec 9;7(12):201156. doi: 10.1098/rsos.201156. eCollection 2020 Dec.
Sensitive, simple and green analytical methodology for simultaneous estimation of bambuterol and montelukast as a combined medication based on their native fluorescence character was developed. The method relies on synchronous spectrofluorimetry to solve the problem of the overlapping emission spectra of the studied drugs. Using second derivative synchronous spectra enabled the simultaneous quantitation of bambuterol and montelukast without interference. The peak amplitudes of the aqueous solutions at Δ = 20 nm were estimated at 284 and 304 nm for bambuterol and at 374 and 384 nm for montelukast. A linear relationship was achieved over the concentration range of 0.2-1.00 µg ml for bambuterol and 0.4-2.00 µg ml for montelukast. All factors and parameters were carefully studied to obtain the highest sensitivity and good precision of the proposed method. Additionally, the validation criteria were assessed in accordance with International Council of Harmonization (ICH) guidelines. The method was used for the estimation of both drugs in their raw materials, synthetic mixtures as well their combined tablets with good agreement between its results and those from the comparison method.
基于班布特罗和孟鲁司特的天然荧光特性，开发了一种灵敏、简便且绿色的分析方法，用于同时测定作为复方药物的班布特罗和孟鲁司特。该方法依靠同步荧光光谱法解决所研究药物发射光谱重叠的问题。使用二阶导数同步光谱能够同时定量班布特罗和孟鲁司特而不受干扰。在Δ = 20 nm时，班布特罗水溶液的峰高在284和304 nm处测定，孟鲁司特在374和384 nm处测定。班布特罗在0.2 - 1.00 µg/ml浓度范围内、孟鲁司特在0.4 - 2.00 µg/ml浓度范围内呈线性关系。仔细研究了所有因素和参数，以获得所提方法的最高灵敏度和良好精密度。此外，按照国际协调理事会（ICH）指南评估了验证标准。该方法用于测定原料药、合成混合物以及复方片剂中的两种药物，其结果与对照方法的结果吻合良好。
