Flourimetric study on antidiabetic combined drugs; empagliflozin and linagliptin in their pharmaceutical formulation and human plasma

Elmasry, Manal S.; Hasan, M. A.; Hаssаn, Wаfаа S.; Merey, Hanan A.; Nour, Israa M.

doi:10.1016/j.saa.2020.119258

Cited by 16 publications

(6 citation statements)

References 18 publications

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“…2-AP and 3-AP are efficient fluorophores as a result of (π-π * ) nature of the lowest excited state 23 . Meanwhile, the cited drugs (PX, TX, ALO and LIN) are not or very weakly fluorescent compounds 24 – 27 , therefore, 2-AP and 3-AP can be determined quantitatively without any interference from these drugs. Different parameters that affect the fluorescent signals of 2-AP and 3-AP were thoroughly studied and optimized.…”

Section: Resultsmentioning

confidence: 99%

Spectrofluorimetric determination of selected genotoxic impurities in pharmaceutical raw materials and final products

Shallan

Abdel-Hakim

Hammad

et al. 2022

Sci Rep

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A green spectrofluorimetric method was introduced for the determination of selected genotoxic impurities; 2-aminopyridine and 3-aminopyridine in different pharmaceutical raw materials and dosage forms. The method relied on the native fluorescence of these impurities in acidic medium. The experimental conditions were carefully studied and optimized, and the method was validated according to International Council on Harmonisation (ICH) guidelines. The linear range for both analytes was 2.50–100 ng/mL with good determination coefficients of 0.9995 and 0.9992 and detection limits of 0.62 ng/mL and 0.74 ng/mL for 2-aminopyridine and 3-aminopyridine, respectively. The method was successfully applied for determination of 2-aminopyridine and 3-aminopyridine in four active pharmaceutical ingredients and nine dosage forms with satisfactory percentage recoveries and without interference from co-formulated excipients. Analytical performance of the proposed method was comparable to that of the reported methods; hence, the proposed method can be used as a simple and low-cost alternative in quality control laboratories.

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Section: Resultsmentioning

confidence: 99%

Spectrofluorimetric determination of selected genotoxic impurities in pharmaceutical raw materials and final products

Shallan

Abdel-Hakim

Hammad

et al. 2022

Sci Rep

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“…It is most selective method in SEE, based on acidic drugs can be isolated with quaternary amine bonded silica or Si-NH2 as an anion exchange, for basic drugs strong cation exchange, Si-SCX and week cation exchange, Si-WCX can be used for isolating the cationic analytes 34 .…”

Section: Ion Exchange-solid Phase Extractionmentioning

confidence: 99%

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

Kemiset¹

2023

Journal of Pharmaceutical Negative Results

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The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in marketing approval. The objective of this paper is to review the method development, Impurity profile study, Degradation studies of the method for the drug production i.e Empagliflozin (EMP) and Linagliptin (LIN) from the developmental stage of the formulation to commercial batch of the product. Bioanalysis plays a vital role in drug discovery and development for the analysis of analytes (drugs, metabolites) in biological samples. To achieve a stable, reliable, and robust method one has to remove the interfaces from the sample matrix to improve bioanalytical system performance. This review provides an overview of the Impurity profile, Degradation study and various Analytical/Bio-Analytical method development of selected Anti-Diabetic drugs i.e EMP and LIN in single dosage form and their combination and a detailed investigation of different analytical techniques used for detection and quantification of these drugs on various matrices. Various techniques like spectroscopy, chromatography, electrochemical methods, and hyphenated techniques were reported to determine Anti-Diabetic drugs, either alone or in combination with other drugs, in different kinds of matrices like in bulk, existing dosage forms and also biological samples like plasma, serum, urine and myocardial tissue. Among various techniques used, HPLC, LC-MS systems are more commonly used because of their high sensitivity. This article summarizes the research works carried out since 2015 and intends to act as a handbook for future researchers.

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“…The collected samples will be analyzed by the present method to be the first spectrofluorometric method for the assay of EMP in real human plasma. In contrast with reported spectrofluorometric and chromatographic methods [2,4,38,[40][41][42], this method affords a highly sensitive, economical, and non-complicated procedure, and it functions as an alternative tool to other described bioanalytical methods, particularly in developing countries.…”

Section: Fourier Transform Infrared (Ftir) Spectroscopymentioning

confidence: 99%

Combined experimental/computational aspects for the molecular interaction of empagliflozin with bovine serum albumin: Quantification and application to human plasma

2023

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Empagliflozin (EMP) is an oral antihyperglycemic agent for type 2 diabetic patients.The molecular binding of EMP to bovine serum albumin (BSA) was elucidated by a combined experimental/computational approach to fulfil the pharmacokinetics and pharmacodynamics gaps of the cited drug for further development. Fluorescence, synchronous, and three-dimensional fluorescence spectroscopy verified that EMP quenched BSA native fluorescence through a dual static/dynamic mechanism that was further supported by Fӧrster resonance energy transfer and ultraviolet absorption spectroscopy. Fourier transform infrared spectroscopy revealed the conformational variations in BSA secondary structure induced by EMP. Thermodynamic properties of the BSA-EMP complex were also investigated, and the hydrophobic interactions' role in the binding process was demonstrated by the computed enthalpy (ΔH = 6.558 kJ mol À1 ) and entropy (ΔS = 69.333 J mol À1 K À1 ). Gibbs free energy (ΔG) values were negative at three distinct temperatures, illuminating the spontaneity of this interaction. In addition, molecular docking studies depicted the optimal fitting of EMP to BSA on Site I (sub-domain IIA) through three hydrogen bonds.Additionally, and based on the quenching effect of EMP on BSA fluorescence, this study suggests a simple validated spectrofluorometric method for the quantitation of the studied drug in bulk form and human plasma samples with reasonable recoveries (96.99-103.10%).

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Flourimetric study on antidiabetic combined drugs; empagliflozin and linagliptin in their pharmaceutical formulation and human plasma

Cited by 16 publications

References 18 publications

Spectrofluorimetric determination of selected genotoxic impurities in pharmaceutical raw materials and final products

Spectrofluorimetric determination of selected genotoxic impurities in pharmaceutical raw materials and final products

A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

Combined experimental/computational aspects for the molecular interaction of empagliflozin with bovine serum albumin: Quantification and application to human plasma

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