Green chromatographic methods for simultaneous micro-determination of empagliflozin, linagliptin with metformin and its pharmacopoeial impurities in pure form and triple combination tablets: A comparative study

El-Kafrawy, Dina S.; El-Shoubashy, Ola H.; Issa, Ahmed E.; Beltagy, Y. A.

doi:10.1016/j.scp.2021.100560

Cited by 12 publications

(7 citation statements)

References 18 publications

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“…A statistical comparison was made between the ndings produced by the present HPLC technique and those obtained by a previously described method [21]. The estimated t and F values are fewer than the tabular values, indicating that there is no statistically signi cant difference between them as illustrated in Table 5.…”

Section: Discussionmentioning

confidence: 87%

“…CYG is also known to have an irritant impact on the skin and eyes [14]. AS far as we know, many HPLC methods have been published for the simultaneous measurement of EMP, LIN, and MET mixture alone or in combination with other anti-diabetic medications [15][16][17][18][19][20][21]. The FDA just approved a new combination tablet dosage form, and earlier methods did not work with it.…”

Section: Introductionmentioning

confidence: 99%

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HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

Bahgat

Hashem

Saleh

et al. 2022

Preprint

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Gliflozins and gliptins are two distinct groups of pharmacological drugs that reduce blood glucose levels in individuals with type II diabetes in various ways that may perform their functions harmoniously. Trijardy® tablet, which contains empagliflozin, linagliptin, and metformin, was recently approved. The scientific database does not yet have a method that is sensitive enough to quantify the aforementioned medications in the presence of metformin official toxic impurities melamine and cyanoguanidine. Molecular docking modeling was utilized in this work to further prove the toxicity of melamine. The five analytes listed before were quantified using RP-HPLC-diode array detector and a Zorbax® C8 column (4.6 × 250 mm, 5 μm) with isocratic mobile phase composed of acetonitrile and 0.05 M potassium dihydrogen phosphate buffer, which had been treated by ο-phosphoric acid to restore a pH of 4.0 (90:10, v/v) at a flow rate of 1.2 mL/min and the eluted peaks were scanned at 250 nm. The utilization of the simplest isocratic elution mode give the current technique a significant time-and cost-saving benefit. The current method can quantify the triple therapy agents in the presence of each other as well as with two official toxic impurities of metformin in one short analytical run.

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Section: Discussionmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

Bahgat

Hashem

Saleh

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…For preliminary judgement on the greenness of the developed method we employed the simple semi-quantitative Analytical Eco-scale (AES) tool ( Gałuszka et al, 2012 ). While, for the sake of obtaining a more comprehensive comparison between our method and different published analytical procedures in terms of their ecological effect, it is highly recommended to combine more than one GAC metric, where synergistic results allow for rational ranking of these procedures ( El-Kafrawy et al, 2022a ; El-Kafrawy et al, 2022b ). This is usually achieved when specially combining the inclusive Green Analytical Procedure Index (GAPI) metric ( Płotka-Wasylka, 2018 ) and the more informative analytical greenness (AGREE) tool ( Pena-Pereira et al, 2020 ).…”

Section: Resultsmentioning

confidence: 99%

Eco-friendly stability-indicating HPTLC micro-determination of the first FDA approved SARS-CoV-2 antiviral prodrug Remdesivir: Study of degradation kinetics and structural elucidation of the degradants using HPTLC-MS

Abo-Gharam

El-Kafrawy²

2022

Sustainable Chemistry and Pharmacy

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“…While, EMP and MET were investigated using spectrophotometric [22][23][24][25][26][27] and chromatographic [20,21,[28][29][30][31][32][33][34][35] methods in pure and pharmaceutical form. Few published researches have discussed the simultaneous determination of the studied drugs with MEL [36][37][38][39][40][41][42].…”

Section: Introductionmentioning

confidence: 99%

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

Fawzy

Said

2023

J of Separation Science

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Molecular modeling is the science of representing molecular structures numerically and simulating their behavior with the equations of quantum and classical physics. Coupling molecular modeling and simulation with chromatographic resolution for pharmaceutical products constitutes a new technique in pharmaceutical analysis. An innovative high-performance liquid chromatographic (HPLC) methodology was developed for the quantification of metformin hydrochloride (MET), empagliflozin (EMP), and canagliflozin (CAN) in bulk, laboratory-developed combinations, pharmaceutical tablets, and in the presence of melamine. Chromatographic separation was accomplished using a Symmetry column with 0.03 M potassium dihydrogen phosphate buffer and 0.02 M heptane sulphonic acid: acetonitrile as the mobile phase. Molecular modeling using molecular operating environment software was applied to properly select the stationary phase suitable for the developed HPLC method. Additionally, molecular modeling estimates and validates binding between the studied analytes and the stationary phase to clarify and explain the chromatographic separation and elution order. In accordance with the International Conference of Harmonization recommendations, the method was validated in terms of linearity, accuracy, precision, and selectivity. The linearity ranges (μg/ml) were 200-1500 (MET), 2-15 (EMP), and 20-150 (CAN) and the limit of detection values were in the ranges of 0.17-54.58 μg/ml. Analysis of pharmaceutical tablets using the suggested approach yielded satisfactory outcomes. As a result, it might be used in quality control laboratories to analyze the aforementioned medications.

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Green chromatographic methods for simultaneous micro-determination of empagliflozin, linagliptin with metformin and its pharmacopoeial impurities in pure form and triple combination tablets: A comparative study

Cited by 12 publications

References 18 publications

HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

Eco-friendly stability-indicating HPTLC micro-determination of the first FDA approved SARS-CoV-2 antiviral prodrug Remdesivir: Study of degradation kinetics and structural elucidation of the degradants using HPTLC-MS

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

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