Article
Analytical approach for conversion of conventional to green RP-HPLC methods for analysis of lipophilic neutral and basic active pharmaceutical ingredients
Bojana Vulovska Trifunovska, Ana Atanasova, Packa Antovska, Katerina Brezovska, Aneta Dimitrovska, Natalia Nakov
Abstract
Conventional RP-HPLC methods commonly used in the pharmaceutical industry require conversion toward more sustainable alternatives in order to reduce the negative environmental impact and enhance workplace safety. This conversion would be greatly simplified if isoeluotropic series existed between conventional and green eluents. The aim of this research was to develop a simple and practical analytical approach based on the elution strength of solvents, applicable for conversion of conventional to green RP-HPLC methods used for lipophilic neutral and basic active pharmaceutical ingredients (APIs). The elution strength of ethanol (EtOH) was estimated using the adsorption (log-log, ADS) retention model across four octadecyl silica stationary phases, employing five neutral and seven basic lipophilic APIs. For lipophilic neutral APIs the volumetric fraction (φ) of MeOH corresponded to 1.6 φ EtOH, while φ of acetonitrile (ACN) to about 1.1 φ EtOH. In the case of lipophilic basic APIs, φ MeOH = 1.5 φ EtOH and φ ACN = 1.0 φ EtOH. The proposed approach enables simple and easy conversion of the used φ, without modifying other chromatographic parameters. The applicability of this approach was verified through successful conversion of conventional RP-HPLC methods used for assay determination of dapagliflozin propylene glycol monohydrate, bisacodyl and diazepam.
Keywords
green RP-HPLC conversion, EtOH-based mobile phase, retention model, lipophilic neutral APIs, lipophilic basic APIs, isoeluotropic series
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