Özet:

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.

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