RESUMEN
The present research has established a quick and highly sensitive second-derivative synchronous fluorometric technique for the simultaneous quantification of a binary mixture of olmesartan medoxomil and rosuvastatin calcium. Simultaneously, the suggested approach was used to detect the synchronous fluorescence intensity of the cited drugs at Δ λ = 80 nm in ethanol to determine the concentrations of olmesartan medoxomil and rosuvastatin calcium at 265 and 240 nm, respectively. Various experimental conditions were tested, and each variable was analyzed and optimized. The calibration graphs were shown to be linear within ranges of 0.1-2.0 and 0.5-6.0 µg ml-1 for each drug concentration, respectively. The newly developed Green Solvents Selecting Tool (GSST) was utilized to assess the solvent's sustainability. Furthermore, the proposed method was found to be environmentally friendly after being evaluated with three different tools [the Green Analytical Procedure Index (GAPI), the Analytical Greenness Metric (AGREE), and the Analytical Eco-Scale with Eco-score equal to 95]. The whiteness qualities were also studied using the Red-Green-Blue (RGB12) model, which was recently designed and showed a high score equal to 92.9. The proposed method's good findings, as well as its ongoing sustainability, simplicity, and economy, stimulate its application in QC laboratories.
RESUMEN
In this study, a green stability indicating chromatographic methods were developed and validated for the quantitative determination of tenofovir alafenamide in the presence of its degradation products in bulk powder as well as in dosage forms. The first method was micellar UPLC in which separation was achieved on kinetex ® 1.7 µm HILIC 100A, LC column using an ecofriendly micellar mobile phase consisting (0.05 M sodium dodecyl sulphate and 0.05 M sodium dihydrogen phosphate, (pH 5.5) and 10% 1-propanol (70:30) at a flow rate of 1 mL min-1 with a UV detection at 210 nm. The second method depended on HPTLC method performed on HPTLC plates pre-coated with silica gel 60 F254 using a mobile phase consisting of n-butanol-acetic acid (7:3, v/v) and detection at 260 nm. Tenofovir alafenamide was subjected to stress conditions including alkaline and acidic degradation. Beer' law was obeyed over the concentration range of 1-18 µg mL-1 and 0.1-4 µg/spot for micellar UPLC and HPTLC methods, respectively. Both methods are successfully applied to the analysis of the drug in its tablets and validated according to ICH guidelines. In addition, their greenness was assessed using three different tools indicating their least hazardous effect on the environment.
