Implementation of two sustainable chromatographic methods for the simultaneous micro-quantitation and impurity profiling of metformin and rosuvastatin in recently approved fixed dose pills: Greenness and whiteness studies

Elbordiny, Haydi S.; Elonsy, Sohila M.; Daabees, Hoda G.; Belal, Tarek S.

doi:10.1016/j.scp.2022.100885

Cited by 12 publications

(7 citation statements)

References 22 publications

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“…The hydrophobicity basis is the key factor controlling the neutral compounds separation. 25,27 Applying the aforementioned postulates in our case, the migration order is NMV at 4.51 min followed by RIT at 6.43. This may be mainly attributed to the hydrophobicity basis that NMV is more water soluble than RIT (NMV 0.0277 mg mL −1 (ref.…”

Section: Resultsmentioning

confidence: 97%

“…The higher the affinity of the drug to micelles, the slower the migration is and vice versa. 25,27 These ndings explain the migration order of anionic, cationic, and neutral analytes. According to the charge on the analyte, electrostatic repulsion exists between anions and SDS micelles due to the similarity of negative charge on both of them, so anionic samples move with the bulk solution, and their migration times are nearby the EOF.…”

Section: Resultsmentioning

confidence: 99%

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Tailoring two white chromatographic platforms for simultaneous estimation of ritonavir-boosted nirmatrelvir in their novel pills: degradation, validation, and environmental impact studies

Elbordiny,

Alzoman,

Maher

et al. 2023

RSC Adv.

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Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

Tailoring two white chromatographic platforms for simultaneous estimation of ritonavir-boosted nirmatrelvir in their novel pills: degradation, validation, and environmental impact studies

Elbordiny,

Alzoman,

Maher

et al. 2023

RSC Adv.

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“…Moreover, the obtained chart depicts the percentages of each color specified, with the outcome of their combination, which is whiteness. The most efficient, accurate, and sustainable analytical approach would yield a high overall percentage and be defined as “white” 52 , 53 .…”

Section: Resultsmentioning

confidence: 99%

In-lab synthesized turn-off fluorescence sensor for estimation of Gemigliptin and Rosuvastatin polypill appraised by Spider diagram, AGREE and whiteness metrics

Mohyeldin,

Talaat,

Kamal

et al. 2024

Sci Rep

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Gemigliptin-Rosuvastatin single-pill combination is a promising therapeutic tool in the effective control of hyperglycemia and hypercholesterolemia. Organic sensors with high quantum yields have profoundly significant applications in the pharmaceutical industry, such as routine quality control of marketed formulations. Herein, the fluorescence sensor, 2-Morpholino-4,6-dimethyl nicotinonitrile 3, (λex; 226 nm, λem; 406 nm), was synthesized with a fluorescence quantum yield of 56.86% and fully characterized in our laboratory. This sensor showed high efficiency for the determination of Gemigliptin (GEM) and Rosuvastatin (RSV) traces through their stoichiometric interactions and simultaneously fractionated by selective solvation. The interaction between the stated analytes and sensor 3 was a quenching effect. Various experimental parameters and the turn-off mechanism were addressed. The adopted approach fulfilled the ICH validation criteria and showed linear satisfactory ranges, 0.2–2 and 0.1–1 μg/mL for GEM and RSV, respectively with nano-limits of detection less than 30 ng/mL for both analytes. The synthesized sensor has been successfully applied for GEM and RSV co-assessment in their synthetic polypill with excellent % recoveries of 98.83 ± 0.86 and 100.19 ± 0.64, respectively. No statistically significant difference between the results of the proposed and reported spectrophotometric methods in terms of the F- and t-tests. Ecological and whiteness appraisals of the proposed study were conducted via three novel approaches: the Greenness Index via Spider Diagram, the Analytical Greenness Metric, and the Red–Green–Blue 12 model. The aforementioned metrics proved the superiority of the adopted approach over the previously published one regarding eco-friendliness and sustainability. Our devised fluorimetric turn-off sensing method showed high sensitivity, selectivity, feasibility, and rapidity with minimal cost and environmental burden over other sophisticated techniques, making it reliable in quality control labs.

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“…Recently, it has been widely acceptable that accomplished analytical platforms should be assessed using at least one greenness assessment metric and/or multicriteria approach tools in order to ensure analytical performance, sustainability, benign environmental impact and economic cost. The trendiest metrics used were the Analytical GREEnness Metric Approach and Software (AGREE) [ 45 , 56 – 59 ] and the RGB 12 model [ 3 , 58 , 59 ]. The proposed method was compared in the matter of greenness and whiteness with different selected reported techniques: spectrophotometry [ 22 ], HPLC–UV [ 60 ], gas chromatography with flame ionization detection (GC-FID) [ 60 ], ultra‐high‐performance supercritical fluid chromatography (UHPSFC) [ 61 ], HPTLC [ 62 ] and ultra-performance liquid chromatography-tandem triple quadrupole compound linear ion trap mass spectrometry (UPLC-Q-TRAP/MS) [ 63 ].…”

Section: Resultsmentioning

confidence: 99%

Development of a sustainable multianalyte MEKC method for quantitation of the antihyperlipidemic drugs ezetimibe together with three statins. Greenness and whiteness appraisal studies

Elbordiny,

Elonsy,

Daabees

et al. 2023

BMC Chemistry

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Implementing powerful and sustainable research that complies with green analytical chemistry (GAC) and white analytical chemistry (WAC) fundamentals can downsize the environmental compliance costs and fruitfully affects practical and economic issues. Within this framework, rapid and white analytical micellar electrokinetic capillary chromatography (MEKC) methodology was developed for the synchronized estimation of the antihyperlipidemic drugs Ezetimibe (EZE), Atorvastatin (ATO), Rosuvastatin (ROS) and Simvastatin (SIM). The technique was established using fused silica capillary (50 cm, 50 µm id) and the background electrolyte was 0.025 M borate buffer pH 9.2 containing 0.025 M sodium dodecyl sulfate (SDS) and 10% v/v acetonitrile as the organic modifier. Diode array detector was adjusted at 243 nm for ATO and ROS and 237 nm for EZE and SIM. Separation was accomplished within 10 min with migration times of 4.12, 5.42, 8.23 and 8.74 min for ROS, ATO, EZE and SIM respectively. The 4 drugs were quantitated in the concentration range of 10–100 μg/mL and the correlation coefficients were not less than 0.9993. The high sensitivity was illustrated by values of the detection and quantitation limits. The limits of detection for ROS, ATO, EZE and SIM were 0.52, 0.75, 0.42 and 0.64 μg/mL, respectively, whereas, the limits of quantitation values were 1.73, 2.50, 1.40 and 2.13 μg/mL for the studied drugs, respectively. In addition to validation, as reported by the ICH guidelines, greenness and whiteness assessment using the novel AGREE calculator and the holistic functionality model RGB12 were performed. The results proved the efficiency and whiteness of the suggested technique to be routinely implemented in quality control laboratories for the assay of the four drugs and the binary mixtures of EZE with either ATO, ROS or SIM in fixed-dose combined tablets.

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Implementation of two sustainable chromatographic methods for the simultaneous micro-quantitation and impurity profiling of metformin and rosuvastatin in recently approved fixed dose pills: Greenness and whiteness studies

Cited by 12 publications

References 22 publications

Tailoring two white chromatographic platforms for simultaneous estimation of ritonavir-boosted nirmatrelvir in their novel pills: degradation, validation, and environmental impact studies

Tailoring two white chromatographic platforms for simultaneous estimation of ritonavir-boosted nirmatrelvir in their novel pills: degradation, validation, and environmental impact studies

In-lab synthesized turn-off fluorescence sensor for estimation of Gemigliptin and Rosuvastatin polypill appraised by Spider diagram, AGREE and whiteness metrics

Development of a sustainable multianalyte MEKC method for quantitation of the antihyperlipidemic drugs ezetimibe together with three statins. Greenness and whiteness appraisal studies

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