High-performance Liquid Chromatography Analysis of Nebivolol and Amlodipine and Some Related Compounds in Synthetic Mixture

Bezmiâlem Science

Çiğdem ALUǹ  Cem ÖNAL²  Kadir ALUdz  Armağan ÖNAL³ 

[1] Abdi İbrahim Medicine Company, Production, İstanbul, Turkey;Cinnagen Medicine Company, Project Director, İstanbul, Turkey;İstanbul University Faculty of Pharmacy, Department of Analytical Chemistry, İstanbul, Turkey;

关键词: nebivolol;    amlodipine;    high-performance liquid chromatography;    validation;    synthetic mixture;   

DOI  :  10.14235/bas.galenos.2020.4372

来源: DOAJ

【 摘 要 】

Objective:This study aimed to develop and validate a method using a high-performance liquid chromatography (HPLC) to perform a quantitative analysis of nebivolol (NEB) and amlodipine (AML) along with some related substances in the synthetic mixture.Methods:The separation in the described chromatographic system was accomplished using a mobile phase consisting of a mixture of acetate buffer (pH: 4.5) and acetonitrile and a HPLC C18 column (150 mm x 4.6 mm, 2.6 μm) with gradient elution on a consistent flow rate of 1.3 mL/min. Photodiode array detection was carried out at a wavelength of 265 nm. According to The International Conference on Harmonisation guidelines, the drug was exposed to various stress conditions; including photolysis, oxidation, thermal degradation and hydrolysis under acidic, basic and neutral mediums.Results:Ranges of detection and quantitation limits were determined to be 0.2-10.0 μg.mL-1 and 0.25-10.0 μg.mL-1 for NEB and AML, respectively. The relative standard deviation values within and between days precision were determined to be <2%. For all substances, the average recovery values were determined within the range of 98.00%-101.50%.Conclusion:We conclude that this developed analytical procedure applies to the quality control of drug formulations.

【 授权许可】

Unknown