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

Abstract

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.

Highly sensitive high‐performance thin‐layer chromatography method for the simultaneous determination of molnupiravir, favipiravir, and ritonavir in pure forms and pharmaceutical formulations

“…Among such metrics, two recent ones have gained a great momentum during the past few years [36]. In 2018, Płotka-Wasylka introduced the green analytical procedure index (GAPI) [37], then in 2020, Pena-Pereira et al developed AGREE assessment metric [38].…”

Potentiometric Sensor Arrays Based on Hybrid PFSA/CNTs Membranes for the Analysis of UV-Degraded Drugs

“…This is due to the fact that some side components may greatly affect the safety and effectiveness of drugs. High-performance (HP) liquid chromatography (LC) with UV detection [ 1 , 2 ], reversed-phase HPLC with photodiode array [ 3 , 4 , 5 ], UV [ 6 , 7 ] or fluorescence [ 7 ] detectors, HP thin-layer chromatography with densitometry [ 1 , 2 , 4 ], capillary zone electrophoresis [ 8 , 9 , 10 ], and spectrophotometry combined with chemometrics [ 11 , 12 , 13 , 14 , 15 , 16 ] can be used to control the degradation and purity of drugs. At the same time, there are two main approaches to the analysis.…”

Design of an Experimental Study for the Simultaneous Determination of Cefepime, Piperacillin and Tazobactam Using Micellar Organic Solvent-Free HPLC

“…It offers the benefit of enabling direct injection of physiologi ples because proteins are dissolved in the surfactant [11], which makes them easi move. MLC has this advantage of replacing hazardous organic solvents in reverse chromatography [12]. Design of experiments (DOE) is a recently established ap that uses a systematic way to find relationships between analytical process variab a better way for understanding the effect of many factors which collectively con crucial analytical process better than the one-factor-at-a-time (OFAT) method [ multiple factors, DOE could also interpret whether these factors have interactive b on the analytical procedure response [14].…”

“…It offers the benefit of enabling direct injection of physiological samples because proteins are dissolved in the surfactant [11], which makes them easier to remove. MLC has this advantage of replacing hazardous organic solvents in reversed-phase chromatography [12]. Design of experiments (DOE) is a recently established approach that uses a systematic way to find relationships between analytical process variables.…”