Greenness assessment as per Eco-scale and AMVI metrics for the chromatographic assay of selected drugs in a semisolid dosage form and in tissues

Abstract

A simple green sample preparation procedure and RP-HPLC method were developed and validated for the determination and quantification of two anti-hemorrhoid drugs in semisolid dosage form as well as in rat rectal tissues. Sample cleanup was performed using solid-phase extraction on strata-X prefilled (100 mg, particle size 33 µm, 3 ml) cartridges; conditions were optimized to obtain maximum recoveries and minimal baseline noise. Separation was carried out on Xselect C18 column (250 × 4.6 mm id, 5 µm particle size), a mobile phase consisting of ethanol: 0.01% aqueous sodium carbonate solution (75:25 by volume) at a flow rate of 1 ml/min and UV detection at 220 nm. The method was validated as per the ICH guidelines and FDA guidance for bioanalytical method validation. Greenness of the method was assessed throughout the whole procedure of sample preparation, separation and quantification using Eco-scale and analytical method volume intensity metrics and was found to be environmentally friendly as it was also manifested by its greenness profile. The developed method was found to be suitable for the determination of the selected drugs in their marketed formulation as well as in biological samples. Being simple and eco-friendly technique, it can be used for routine analysis in quality control laboratories.