Eco-Friendly and Sensitive HPLC and TLC Methods Validated for the Determination of Betahistine in the Presence of Its Process-Related Impurity

Separations

article

Adel Ehab Ibrahim¹  Sami El Deeb³  Hisham Ezzat Abdellatef⁴  Hassan A. M. Hendawy⁵  Omar M. El-Abassy⁶  Hany Ibrahim⁶ 

[1]Analytical Chemistry Department, Faculty of Pharmacy, Port-Said University

[2]Natural and Medical Sciences Research Center, University of Nizwa

[3]Institute of Medicinal and Pharmaceutical Chemistry, Technische Universitaet Braunschweig

[4]Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University

[5]National Organization for Drug Control and Research

[6]Analytical Chemistry Department, Faculty of Pharmacy, Egyptian Russian University

关键词: betahistine;    process-related impurities;    HPLC;    TLC;    mixed micellar chromatography;   

DOI  :  10.3390/separations9020049

学科分类：社会科学、人文和艺术（综合）

来源: mdpi

【 摘 要 】

Reducing the amounts consumed of organic solvents while keeping good chromatographic performance has been a significant step towards the greening of analytical methodologies. When sodium dodecyl sulfate (SDS) and Brij-35 surfactants are combined in a mobile phase, they can be used as a green alternative to organic modifiers. Surfactants have numerous advantages, including low cost and toxicity, safe environmental disposal, and unique selectivity, in addition to high solubilization capabilities. In this research, two highly selective chromatographic methods were adopted for the determination of betahistine (BHS) in the presence of its pharmacopeial impurity 2-(2-hydroxyethyl)pyridine (HEP). A solvent-free HPLC method was validated, in which the mixture was separated using a C18 column (3.5 µm, 75.0 × 4.6 mm) and a mobile phase composed of 0.01 M Brij-35, 0.12 M SDS, and 0.02 M disodium hydrogen phosphate adjusted to a pH of 5.5 using phosphoric acid. The flow rate was 1.5 mL min−1 and the resolved peaks were detected at 260 nm. Another HPTLC-densitometric method was validated using HPTLC aluminum plates coated with silica gel 60 F254 as the stationary phase and a developing system consisting of methylene chloride/methanol/ethyl acetate/ammonia (at a ratio of 5:2:2:0.2 by volume); the separated bands were scanned at 260 nm.

【 授权许可】

CC BY