Mohammed Fatma F, Badr El-Din Khalid M, Derayea Sayed M
Analytical Chemistry Department, Faculty of Pharmacy, Minia University Minia Egypt
Analytical Chemistry Department, Faculty of Pharmacy, Deraya University Minia Egypt.
RSC Adv. 2018 May 1;8(29):16269-16277. doi: 10.1039/c8ra01617h. eCollection 2018 Apr 27.
Lisinopril, an ACE inhibitor, was selectively determined in pharmaceutical products using spectrofluorimetry. The method was based on the switch on fluorescamine fluorescence as a result of its interaction with the primary amino group of the drug in the presence of aqueous borate buffer (pH 9.5). The fluorescence emission was measured at 475 nm after excitation at 390 nm. The fluorescent product was suggested to be a diaryl pyrrolone cation which has a coplanar structure. Different experimental conditions affecting the reaction were optimized to give the maximum sensitivity. The fluorescence intensity was linear with the drug concentration in the range of 0.55-4.5 μg mL. The method was validated according to ICH guidelines and the result was acceptable. The calculated limits of detection and quantitation were 0.182 and 0.55 μg mL, respectively. The commercially available dosage forms containing lisinopril alone or in combination with hydrochlorothiazide were effectively analyzed by the proposed method. The obtained results were in agreement with those of the reported method in respect to accuracy and precession. Moreover, the suggested method was employed to determine the content uniformity testing of the investigated dosage forms.
使用荧光分光光度法对药品中的赖诺普利（一种血管紧张素转换酶抑制剂）进行了选择性测定。该方法基于在硼酸盐缓冲液（pH 9.5）存在下，荧光胺与药物的伯氨基相互作用而开启荧光胺的荧光。在390 nm激发后，于475 nm处测量荧光发射。荧光产物被认为是具有共面结构的二芳基吡咯酮阳离子。对影响反应的不同实验条件进行了优化，以获得最大灵敏度。荧光强度与药物浓度在0.55 - 4.5 μg/mL范围内呈线性关系。该方法按照国际人用药品注册技术协调会（ICH）指南进行了验证，结果是可接受的。计算得出的检测限和定量限分别为0.182和0.55 μg/mL。所提出的方法有效地分析了市售的仅含赖诺普利或与氢氯噻嗪联用的剂型。就准确度和精密度而言，所获得的结果与报道方法的结果一致。此外，所建议的方法用于测定所研究剂型的含量均匀度检测。
