Hamad Ahmed A, Ali Ramadan, Ali Hassan Refat H, Nagy Dalia M, Derayea Sayed M
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University Assiut Branch Assiut 71524 Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University Assiut Egypt.
RSC Adv. 2018 Jan 31;8(10):5373-5381. doi: 10.1039/c7ra12360d. eCollection 2018 Jan 29.
Two simple, sensitive, and rapid spectrofluorimetric methods were developed and validated for the determination of albendazole. The first method (method I) was based on the quenching effect of albendazole on the native fluorescence of erythrosine B. The fluorescence intensity was measured at 554 nm after extraction at 527 nm. In the second method (method II) the drug was reacted with lanthanum(iii) ions to form a metal complex, which was measured at 340 nm after excitation at 295 nm. The suitable pH was 3.4 (Teorell-Stenhagen buffer) and pH 5.5 (phosphate buffer solution), for method I and II, respectively. The influence of experimental factors on the fluorescence intensity of the reaction products was investigated and optimized. The linear concentration ranges were 0.2-3.5 and 0.06-0.90 μg mL, with detection limits of 0.049 and 0.019 μg mL for method I and II, respectively. ICH guidelines were followed for validation of the developed procedures, and the results were acceptable. The Gibb's free energy change of the reactions was -24.6 and -27.5 kJ mol for method I and II, respectively. These negative values indicated the high feasibility of these reactions at ambient temperature. The proposed procedures were applied successfully for the determination of albendazole in commercial dosage forms and spiked human plasma. The results showed high precision, accuracy and recovery of the reported methods without any significant interference from pharmaceutical excipients or plasma components.
开发并验证了两种简单、灵敏且快速的分光荧光法用于测定阿苯达唑。第一种方法(方法I)基于阿苯达唑对赤藓红B天然荧光的猝灭作用。在527nm处萃取后,于554nm处测量荧光强度。第二种方法(方法II)中,药物与镧(III)离子反应形成金属络合物,在295nm激发后于340nm处测量。方法I和方法II合适的pH分别为3.4(特奥雷尔 - 斯滕哈根缓冲液)和5.5(磷酸盐缓冲溶液)。研究并优化了实验因素对反应产物荧光强度的影响。线性浓度范围分别为0.2 - 3.5和0.06 - 0.90μg/mL,方法I和方法II的检测限分别为0.049和0.019μg/mL。按照国际协调会议(ICH)指南对所开发方法进行验证,结果是可接受的。方法I和方法II反应的吉布斯自由能变化分别为 - 24.6和 - 27.5kJ/mol。这些负值表明这些反应在环境温度下具有很高的可行性。所提出的方法成功应用于商业剂型和加标人血浆中阿苯达唑的测定。结果表明所报道方法具有高精度、准确性和回收率,且无来自药用辅料或血浆成分的任何显著干扰。