Implantation of impressive chromatographic and built-in UV spectrophotometry approaches for sustainable Estimation of olopatadine and mometasone in pharmaceuticals; eco-scale and BAGI applications

Amal A. El-Masry , Samah A. Elsabour , Ahmed Emad F. Abbas , Yomna A. Salem
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Abstract

The development of analytical methods that adhere to the principles of sustainable green chemistry is essential in the modern scientific arena. This research presents two novel methods for the concurrent quantification of olopatadine (OLO) and mometasone (MOM), targeting sustainable green chemistry principles in their raw materials, dosage forms and combined nasal spray formulations. The first method is a rapid isocratic high-performance liquid chromatography (HPLC) that achieves excellent resolution within 4 min, with retention times of 2.37 ± 0.1 min for OLO and 4.05 ± 0.1 min for MOM. It features optimal sensitivity, with detection limits of 0.13 µg/mL for OLO and 0.03 µg/mL for MOM. It utilizes a cyano column with an isocratic mobile phase of acetonitrile and 0.1 M OPA (50: 50, v/v), making it accessible to standard laboratory equipment. The second method is UV–visible spectrophotometry, which includes first-order derivative measurement (D1) and ratio derivative spectra (RDS) methods. These spectroscopic approaches provide linear response range of 0.2–20.0 µg/mL for OLO and 4.0–40.0 µg/mL for MOM, respectively serving as cost-effective alternatives for labs with limited resources. Validation results show high accuracy (98–102 %) and precision (RSD < 2 %). Green assessments using Eco-Scale indicate scores of 86 for HPLC and 100 for spectrophotometry, while the “blueness” concept via BAGI demonstrates strong sustainability with scores of 87.5 and 90. These methods effectively quantify OLO and MOM in their raw materials, different formulations and combined nasal spray, providing a sustainable and reliable approach for pharmaceutical analysis. This work is the first green assessment for the determination of OLO and MOM in pure drug and in the pharmaceutical formulations using less hazard solvent and simple technique.

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植入令人印象深刻的色谱法和内置紫外分光光度法,实现药品中奥洛他定和莫米他松的可持续估算;生态规模和 BAGI 应用。
在现代科学领域,开发符合可持续绿色化学原则的分析方法至关重要。本研究针对奥洛他定(OLO)和莫美他松(MOM)的原料、剂型和鼻喷雾剂组合配方中的可持续绿色化学原则,提出了两种同时定量分析奥洛他定和莫美他松的新方法。第一种方法是快速等度高效液相色谱法(HPLC),可在 4 分钟内实现出色的分辨率,OLO 和 MOM 的保留时间分别为 2.37 ± 0.1 分钟和 4.05 ± 0.1 分钟。它具有最佳灵敏度,OLO 和 MOM 的检测限分别为 0.13 微克/毫升和 0.03 微克/毫升。该方法采用氰基色谱柱,以乙腈和 0.1 M OPA(50:50,v/v)为等度流动相,适用于标准实验室设备。第二种方法是紫外可见分光光度法,包括一阶导数测量法(D1)和比值导数光谱法(RDS)。这些分光方法的线性响应范围分别为 OLO 0.2-20.0 µg/mL 和 MOM 4.0-40.0 µg/mL,对于资源有限的实验室来说是具有成本效益的替代方法。验证结果表明,该方法具有较高的准确度(98-102 %)和精密度(RSD < 2 %)。使用 Eco-Scale 进行的绿色评估表明,高效液相色谱法和分光光度法的得分分别为 86 分和 100 分,而通过 BAGI 进行的 "蓝度 "概念评估则显示出很强的可持续性,得分分别为 87.5 分和 90 分。这些方法有效地量化了原料、不同配方和复合鼻喷雾剂中的 OLO 和 MOM,为药物分析提供了一种可持续的可靠方法。这项工作是利用危害较小的溶剂和简单的技术测定纯药物和药物制剂中 OLO 和 MOM 的首次绿色评估。
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来源期刊
CiteScore
8.40
自引率
11.40%
发文量
1364
审稿时长
40 days
期刊介绍: Spectrochimica Acta, Part A: Molecular and Biomolecular Spectroscopy (SAA) is an interdisciplinary journal which spans from basic to applied aspects of optical spectroscopy in chemistry, medicine, biology, and materials science. The journal publishes original scientific papers that feature high-quality spectroscopic data and analysis. From the broad range of optical spectroscopies, the emphasis is on electronic, vibrational or rotational spectra of molecules, rather than on spectroscopy based on magnetic moments. Criteria for publication in SAA are novelty, uniqueness, and outstanding quality. Routine applications of spectroscopic techniques and computational methods are not appropriate. Topics of particular interest of Spectrochimica Acta Part A include, but are not limited to: Spectroscopy and dynamics of bioanalytical, biomedical, environmental, and atmospheric sciences, Novel experimental techniques or instrumentation for molecular spectroscopy, Novel theoretical and computational methods, Novel applications in photochemistry and photobiology, Novel interpretational approaches as well as advances in data analysis based on electronic or vibrational spectroscopy.
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