Egyptian Russian University, Faculty of Pharmacy, Pharmaceutical Chemistry Department, Badr City, Cairo 11829, Egypt.
Zagazig University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Zagazig 44519, Egypt.
J AOAC Int. 2024 May 2;107(3):512-518. doi: 10.1093/jaoacint/qsae016.
The presentation of rhinitis has drawn increasing attention in recent years due to the possibility of overlap or confusion between allergic rhinitis symptoms and those of COVID-19. Azelastine hydrochloride (AZH) and mometasone furoate (MOF) are two of the most efficient combinations for enhancing the symptoms of seasonal allergic rhinitis.
This work concerns applying and validating different accurate and simple spectrophotometric approaches for simultaneous quantification of the binary mixture of AZH and MOF in raw material, laboratory-prepared mixtures, and pharmaceutical preparation. Moreover, assessment of the environmental impact of the applied approaches on the environment was also a key goal of this study.
AZH was determined using the direct spectrophotometric (D0) method, while four reliable spectrophotometric approaches namely, induced dual wavelength (IDW), ratio subtraction (RS), ratio difference (RD), and ratio derivative (1DD) were used for MOF determination.
The methods were validated in line with the International Conference of Harmonization standards. In the AZH range of (5-56 µg/mL) and MOF range of (2-20 µg/mL), the linearity of the proposed approaches was investigated with high accuracy findings. There were no significant differences between the obtained results and those of the reported method when compared statistically. Furthermore, the applied spectrophotometric methods were deemed to be eco-friendly according to Green Analytical Procedure Index (GAPI) and Analytical Greenness Calculator (AGREE) assessment metrics.
The applied spectrophotometric methods are simpler, more eco-friendly, and take a shorter time to precisely estimate many measurements compared to the only reported chromatographic analysis.
Neither publications of novel spectrophotometric methods nor reported green ones have been available for simultaneous determination of the binary mixture of AZH and MOF, so this work has a great significance and novelty in the area of pharmaceutical analysis.
近年来，由于变应性鼻炎症状与 COVID-19 症状之间可能存在重叠或混淆，因此变应性鼻炎的表现引起了越来越多的关注。盐酸氮卓斯汀（AZH）和糠酸莫米松（MOF）是增强季节性变应性鼻炎症状的最有效组合之一。
本工作涉及应用和验证不同准确且简单的分光光度法，以同时定量原料药、实验室制备混合物和药物制剂中 AZH 和 MOF 的二元混合物。此外，评估所应用方法对环境的环境影响也是本研究的一个关键目标。
AZH 采用直接分光光度法（D0）测定，而 MOF 则采用四种可靠的分光光度法，即诱导双波长法（IDW）、比值减法法（RS）、比值差法（RD）和比值导数法（1DD）进行测定。
方法按照国际协调会议标准进行验证。在所提出的方法中，AZH 的范围为（5-56μg/mL），MOF 的范围为（2-20μg/mL），考察了其线性度，结果发现具有高精度。与统计学上的报道方法相比，所得结果之间没有显著差异。此外，根据绿色分析程序指数（GAPI）和分析绿色度计算器（AGREE）评估指标，所应用的分光光度法被认为是环保的。
与唯一报道的色谱分析相比，所应用的分光光度法更简单、更环保，并且可以更精确地估计更多的测量值。
目前尚无同时测定 AZH 和 MOF 二元混合物的新型分光光度法或已报道的绿色分光光度法，因此本工作在药物分析领域具有重要意义和新颖性。
