Magdy Galal, El Hamd Mohamed A, El-Maghrabey Mahmoud, Zainy Faten M, Mahdi Wael A, Alshehri Sultan, Alsaggaf Wejdan T, Radwan Aya Saad
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh, Egypt.
Department of Pharmaceutical Sciences, College of Pharmacy, Shaqra University, Shaqra, Saudi Arabia.
Luminescence. 2023 Dec 3. doi: 10.1002/bio.4635.
In this study, the simultaneous determination of bilastine and montelukast, two recently approved co-formulated antihistaminic medications, was accomplished using a quick, sensitive, environmentally friendly, and reasonably priced synchronous fluorescence spectroscopic approach for the first time. Enhancement of the method's sensitivity down to nanogram levels was achieved by the addition of sodium dodecyl sulfate (1.0% w/v) as a micellar system. According to the results, bilastine and montelukast's fluorescence was measured at 255.3 and 355.3 nm, respectively, using Δλ of 40.0 nm and distilled water as a green diluting solvent. With respect to the concentration ranges of bilastine (5.0-300.0 ng/ml) and montelukast (50.0-1000.0 ng/ml), the method showed excellent linearity (r ≥ 0.9998). The results showed that the suggested method is highly sensitive, with detection limits of 1.42 and 13.74 ng/ml for bilastine and montelukast, respectively. Within-run precisions (intra- and interday) per cent relative standard deviations (RSD) for both analytes were <0.59%. With high percentage recoveries and low percentage RSD values, the designed approach was successfully applied for the simultaneous estimation of the cited medications in their dosage form and human plasma samples. To evaluate the green profile of the suggested method, an analytical GREENNESS metric approach (AGREE) and green analytical procedure index (GAPI) metric tools were used. These two methods for evaluating greenness confirmed that the developed method met the highest number of green requirements, recommending its use as a green substitute for the routine analysis of the studied drugs. The proposed approach was validated according to ICHQ2 (R1) guidelines.
在本研究中，首次采用快速、灵敏、环境友好且价格合理的同步荧光光谱法同时测定了比拉斯汀和孟鲁司特这两种最近获批的复方抗组胺药物。通过添加十二烷基硫酸钠（1.0% w/v）作为胶束体系，实现了该方法灵敏度提高至纳克水平。结果表明，使用40.0 nm的Δλ和蒸馏水作为绿色稀释溶剂时，比拉斯汀和孟鲁司特的荧光分别在255.3和355.3 nm处测定。对于比拉斯汀（5.0 - 300.0 ng/ml）和孟鲁司特（50.0 - 1000.0 ng/ml）的浓度范围，该方法显示出良好的线性（r≥0.9998）。结果表明，所建议的方法具有高灵敏度，比拉斯汀和孟鲁司特的检测限分别为1.42和13.74 ng/ml。两种分析物的批内精密度（日内和日间）相对标准偏差（RSD）百分比均<0.59%。该设计方法具有高回收率和低RSD百分比值，成功应用于同时测定所引用药物的剂型和人血浆样品中的含量。为了评估所建议方法的绿色度，使用了分析绿色度指标方法（AGREE）和绿色分析程序指数（GAPI）指标工具。这两种评估绿色度的方法证实，所开发的方法符合最多的绿色要求，建议将其用作研究药物常规分析的绿色替代方法。所提出的方法根据ICHQ2（R1）指南进行了验证。
