Pharmaceutical Analytical Chemistry Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology, 6th of October City, Giza, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr Al-Aini Street, Cairo, 11562, Egypt.
Sci Rep. 2024 Sep 28;14(1):22406. doi: 10.1038/s41598-024-72431-x.
Asthma and chronic obstructive pulmonary disease (COPD) are the most common diagnoses for adults and children with respiratory tract inflammation. Recently, a novel fixed dose combination consisting of Ipratropium and Fenoterol has been released for the management and control of the symptoms of such disorders. The current research has newly developed and optimized three smart, accurate, simple, cost-effective, and eco-friendly spectrophotometric methods that enabled the simultaneous determination of the drugs under study in their combined inhaler dosage form, without the need for any previous separation steps, using water as a green solvent. The strategy employed was based on calculating one or two factors as a numerical spectrum or constant, which provided the complete removal of any component in the mixture that might overlap and the mathematical filtration of the targeted analyte. The methods developed could be classified into two types of spectrophotometric windows. Window I; involved absorption spectrum in their original zero-order forms (°D), which included recently designed methods named induced concentration subtraction (ICS) and induced dual wavelength (IDW). While window III focused on the ratio spectrum as the induced amplitude modulation (IAM) method. The extremely low absorptivity and lack of distinct absorption maximum in the zero-order absorption spectrum of Ipratropium were two intrinsic challenges that were better overcome by the proposed spectrophotometric methods than by the conventionally used ones. According to ICH guidelines, the proposed methods were validated using unified regression over range 2.0-40.0 µg/mL in the ICS method, while the linearity ranges for the IDW and IAM methods were 5.0-40.0 µg/mL of Ipratropium and 2.0-40.0 µg/mL of Fenoterol. Moreover, the three proposed methods were effectively used to assay the co-formulated marketed inhaler and further expanded to confirm the delivered dose uniformity in compliance with the USP guidelines. Finally, the established methods were evaluated for their greenness and blueness, in comparison to the official and reported analysis methods, using advanced cutting edge software metrics. Furthermore, the suggested techniques adhered well to the white analytical chemistry postulates that were recently published.
哮喘和慢性阻塞性肺疾病(COPD)是呼吸道炎症的成人和儿童最常见的诊断。最近,一种新型的固定剂量组合药物,由异丙托溴铵和硫酸沙丁胺醇组成,已被用于管理和控制这些疾病的症状。本研究新开发和优化了三种智能、准确、简单、具有成本效益且环保的分光光度法,可在无需任何先前分离步骤的情况下,使用水作为绿色溶剂,同时测定联合吸入制剂中药物的含量。所采用的策略是基于计算一个或两个因素作为数值光谱或常数,从而完全消除混合物中任何可能重叠的成分,并对目标分析物进行数学过滤。所开发的方法可分为两种分光光度窗口。窗口 I 包括在其原始零阶形式(°D)下的吸收光谱,其中包括最近设计的方法,分别命名为诱导浓度差减(ICS)和诱导双波长(IDW)。而窗口 III 则侧重于比值光谱,即诱导幅度调制(IAM)方法。异丙托溴铵零阶吸收光谱的吸光度极低且缺乏明显的吸收最大值,这两个内在挑战使得所提出的分光光度法比传统方法更具优势。根据 ICH 指南,ICS 方法中在 2.0-40.0 µg/mL 范围内采用统一回归验证了所提出的方法,而 IDW 和 IAM 方法的线性范围分别为 5.0-40.0 µg/mL 的异丙托溴铵和 2.0-40.0 µg/mL 的硫酸沙丁胺醇。此外,所提出的三种方法有效地用于测定市售联合吸入剂,并进一步扩展以符合 USP 指南,确认交付剂量的均匀性。最后,使用先进的尖端软件指标,与官方和报告的分析方法相比,对所建立的方法进行了绿色性和蓝色性评估。此外,所建议的技术符合最近发表的白色分析化学假设。