Simultaneous determination of guaifenesin enantiomers and ambroxol HCl using 50‐mm chiral column for a negligible environmental impact

Abstract

Chiral stationary phases are conveniently used for enantiomeric separation of drugs by liquid chromatography. Consumption of large volumes of hazardous solvents is considered as a common challenge for the sustainability of this technique. To this end, a columnar chromatography has been adopted using 50mm-length stationary phases. The study comprised five Phenomenex Lux cellulose-and amylose-based columns for the separation of guaifenesin (GUA) enantiomers. In addition, an experimental design was used to optimize the gradient profile for the separation of racemic GUA and ambroxol HCl (AMB) binary mixture. The chromatographic method was achieved using Lux Cellulose-1 (50 × 4.6 mm) as a chiral stationary phase and ethanol/water as a mobile phase with linear gradient elution of 20% to 70% ethanol in 6 minutes at a flow rate of 1.0 mL min −1 and UV detection at 270 nm.Linearity ranges were found to be 50 to 1000 μg mL −1 and 15 to 450 μg mL −1 for each GUA enantiomer and AMB, respectively. Environmental, health and safety tool was used to assess and compare greenness of the proposed and reported methods. Short column indeed reduces the environmental impact by decreasing waste by about 60% and utilizing only 1-mL ethanol in the mobile phase. The proposed method is a safer alternative for the simultaneous determination of drugs in their combined pharmaceutical formulation. The method has been validated and compared favorably with a reported one.

Resolving phenylephrine HCl and guaifenesin enantiomers on cellulose‐based chiral stationary phases: Separation of four enantiomers on 50‐mm column

“…GUA enantiomers showed better selectivity on Lux Cellulose‐1 stationary phase using ethanol‐water (25:75, by volume) mobile phase. This result is in concordance with our previous study 18 . Although a good separation of GUA enantiomers is observed, this mobile phase composition is not suitable for the retention or consequent resolution of PHE enantiomers (Figure S1).…”

“…Owing to the use of short column and optimized mobile phase, this novel separation of four enantiomers of PHE and GUA is achieved. The only comparable work is the study of Tantawy et al, 18 where 4.8 ml of ethanol is consumed per rum to separate only two enantiomers. Mean and variance of recoveries obtained through analysis of PHE/GUA samples by the proposed method were statistically compared with those obtained from the reported method 20 via Student's t and F ‐tests, respectively.…”

Polysaccharide- and β-Cyclodextrin-Based Chiral Selectors for Enantiomer Resolution: Recent Developments and Applications

“…Method development towards the reduction in hazardous mobile-phase components, in agreement with green chemistry principles, was taken into consideration by Tantawy et al [ 40 ]. The authors employed different commercial chiral columns with smaller dimensions (50 × 4.6 mm, i.d., 5 μm silica gel), namely, Lux ® Cellulose-1, Lux ® Cellulose-2, Lux ® Cellulose-3, Lux ® Cellulose-4, see Table 1 ), and Lux ® Amylose-2 ( Table 2 ), for the ES of guaifenesin enantiomers ( Supplementary Materials Figure S14 ) in ambroxol hydrochloride binary mixtures.…”

An integrated framework to develop an efficient valid green (EVG) HPLC method for the assessment of antimicrobial pollutants with potential threats to human health in aquatic systems

“…Common LC techniques include classical reversed phase RP-HPLC, 7,8 thin-layer chromatography TLC 9,10 and chiral chromatography. 11 Solvents play the main role in achieving greenness in any LC procedure. This can be reached using small amounts of organic solvents 12 or solvent-free micellar chromatography.…”