Abstract
Three eco-friendly spectrophotometric methods were developed for determination of the novel anticoagulant drug, betrixaban (BTX). The first method (method A) was based on direct analysis of BTX at 229.4 nm on the zero-order spectrum using methanol as the optimum solvent. While the second method (method B) was based on measuring difference absorption value (ΔA) of BTX at 335 nm, which was obtained from pH-induced spectral difference (difference spectra of BTX in 0.1 M NaOH versus 0.1 M HCl). The third method (method C) was based on measurement of the first-derivative amplitudes of BTX and its co-administered Ca channel blocker lercanidipine (LER) at 304 and 229 nm for simultaneous assay of BTX and LER, respectively. All methods were linear over concentration ranges of 1.0–20.0 and 8.0–80.0 µg ml−1 for BTX in methods A and B, respectively, and of 1.0–20.0 and 1.0–25.0 µg ml−1 for BTX and LER, respectively, in method C. The three methods were fully validated and assessed for greenness by three metrics: analytical eco-scale, green analytical procedure index and Analytical GREEnness metrics. The results indicated the validity and greenness of the proposed methods. Moreover, the methods were applied to assay the studied analytes in their dosage forms with high percentage of recovery and low percentage of relative s.d. values.
Highlights
The novel class, non-vitamin K oral anticoagulants provides better therapeutic control with low bleeding complications when compared with other anticoagulant agents [1]
Co-administration of BTX with other Ca channel blocker was very effective in management of atrial fibrillation [3], where the normal blood flow can be interrupted with the irregular heart beat leading to potential risks of blood clots and strokes
The proposed spectrophotometric methods were optimized for the analysis of the novel anticoagulant drug, BTX alone or with its co-administered drug, LER
Summary
The novel class, non-vitamin K oral anticoagulants provides better therapeutic control with low bleeding complications when compared with other anticoagulant agents [1]. Betrixaban (BTX) is a novel synthetic, potent and selective oral anti-coagulant drug. Its chemical name is N-(5-chloropyridin-2-yl)-2-([4-(N,Ndimethylcarbamimidoyl)benzoyl]amino)-5-methoxybenzamide [2] (figure 1). Co-administration of BTX with other Ca channel blocker was very effective in management of atrial fibrillation [3], where the normal blood flow can be interrupted with the irregular heart beat leading to potential risks of blood clots and strokes. BTX as an anticoagulant will prevent formation of blood clots, while a Ca-channel blocker such as lercanidipine (LER) will relax the arterial muscles and reduce the overall heart rate. LER is chemically named as (±)-2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethylmethyl1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl) -3,5pyridinedicarboxylate [4] (figure 1)
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