Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.
Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, El-Messalah, Alexandria 21521, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2018 Nov 5;204:260-266. doi: 10.1016/j.saa.2018.06.057. Epub 2018 Jun 15.
The first spectrofluorimetric report investigating the fluorimetric behavior of the antihistaminic drug, azelastine (AZEL), and the non-steroidal anti-inflammatory drug, nepafenac (NEP), either in bulk or in their dosage forms, eye drops and ophthalmic suspension. After a full investigation of the factors that may influence their spectrofluorimetric behavior: pH, different organized media and organic solvents, the optimum factors were set in order to enable the analysis of each drug with maximum sensitivity. The AZEL spectrofluorimetric analysis was set at 286/364 (λ/λ in distilled water while for NEP, the analysis was set at 228/303 (λ/λ in methanol. The linearity range for AZEL was from 0.1 to 1.5 μg/mL while that of NEP was from 0.2 to 1.5 μg/mL. The linearity yielded good regression parameters with low LOD (0.022 and 0.032 μg/mL for AZEL and NEP, respectively) and LOQ (0.073 and 1.08 μg/mL for AZEL and NEP, respectively) when compared with those obtained from many previous spectroscopic and chromatographic reports in literature. The method was ICH validated and was applied to the analysis of AZEL and NEP with good selectivity regarding the inactive ingredients.
首次报道了抗组胺药氮卓斯汀（AZEL）和非甾体类抗炎药奈帕芬（NEP）在原料药和制剂（滴眼液和眼用混悬剂）中的荧光行为。在全面考察了可能影响其荧光行为的因素（pH 值、不同的有机介质和有机溶剂）后，确定了最佳条件，以实现每种药物的最大灵敏度分析。AZEL 的荧光分析在蒸馏水的 286/364（λ/λ）处进行，而 NEP 的荧光分析在甲醇的 228/303（λ/λ）处进行。AZEL 的线性范围为 0.1 至 1.5μg/mL，而 NEP 的线性范围为 0.2 至 1.5μg/mL。与文献中许多先前的光谱和色谱报道相比，该方法具有良好的回归参数和较低的检出限（AZEL 和 NEP 分别为 0.022 和 0.032μg/mL）和定量限（AZEL 和 NEP 分别为 0.073 和 1.08μg/mL）。该方法经过 ICH 验证，并应用于 AZEL 和 NEP 的分析，对赋形剂具有良好的选择性。
