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一种用于测定药物制剂和生物流体中比拉斯汀的高灵敏度荧光分光光度法。

A highly sensitive spectrofluorimetric method for the determination of bilastine in its pharmaceutical preparations and biological fluids.

作者信息

Radwan Aya Saad, Elkhoudary Mahmoud M, Hadad Ghada M, Belal Fathalla, Salim Mohamed M

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Suez Canal University, Ismailia, Egypt; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University- Egypt, New Damietta, Egypt.

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University- Egypt, New Damietta, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2022 Aug 5;276:121246. doi: 10.1016/j.saa.2022.121246. Epub 2022 Apr 9.

Abstract

Allergic rhinitis and urticaria are extremely prevalent among all age groups. From the clinical experience, usually, an essential second-generation non-sedating H-antihistaminic drug, such as bilastine is given to relieve allergic symptoms. Bilastine is preferred to be used instead of oral corticosteroids and first -generation sedating H-antihistaminics to avoid their side effects. A highly sensitive and simple spectrofluorometric method was developed and validated for the determination of bilastine in its dosage forms and biological fluids. The quantum yield was calculated and was found to be as high as 0.48. Aqueous water solution of bilastine gives high native fluorescence emission at 298 nm after excitation at 272 nm. A rectilinear calibration plot was obtained over the concentration range of 1.0-50.0 ng mL. The limits of quantitation and detection were 1.0 and 0.33 ng mL, respectively. The parameters influencing its spectrofluorimetric behavior, viz, type of solvent, pH and organized media were studied. The proposed method was successfully applied for the determination of the drug in pharmaceutical dosage form and the results obtained were in good agreement with those of given by reported method. The high sensitivity of the proposed method enabled the estimation of the drug in biological matrices, including human plasma and urine samples after simple protein precipitation, and the results obtained were satisfactory.

摘要

变应性鼻炎和荨麻疹在所有年龄组中极为普遍。从临床经验来看,通常会给予一种重要的第二代非镇静性H-抗组胺药,如比拉斯汀,以缓解过敏症状。相较于口服皮质类固醇和第一代镇静性H-抗组胺药,更倾向使用比拉斯汀,以避免其副作用。开发并验证了一种高灵敏度且简单的荧光分光光度法,用于测定比拉斯汀在其剂型和生物流体中的含量。计算了量子产率,发现高达0.48。比拉斯汀的水溶液在272nm激发后,于298nm处发出高本底荧光。在1.0 - 50.0 ng mL的浓度范围内获得了线性校准曲线。定量限和检测限分别为1.0和0.33 ng mL。研究了影响其荧光分光光度行为的参数,即溶剂类型、pH值和有序介质。所提出的方法成功应用于药物剂型中药物的测定,所得结果与报道方法给出的结果吻合良好。所提出方法的高灵敏度使得能够在简单的蛋白质沉淀后,对包括人血浆和尿液样本在内的生物基质中的药物进行测定,所得结果令人满意。

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