Development of LC-MS/MS method for simultaneous determination of Canagliflozin and Metformin in human plasma and its pharmacokinetic application in Indian population under fast and fed conditions

Wattamwar, Tejas; Mungantiwar, Ashish; Gujar, Supriya; Pandita, Nancy

doi:10.1016/j.jchromb.2020.122281

Cited by 15 publications

(6 citation statements)

References 24 publications

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“…A review of the literature revealed that different methods were reported for the estimation of GAG either alone (Alam et al, 2020) or in combination with other antidiabetic drugs (Sharif et al, 2020;van der Aart-van der Beek et al, 2020). Also literature review reveals different methods for the simultaneous estimation of CAG and MEF using spectrophotometric (Lotfy et al, 2018;Moussa et al, 2018;Wafaa et al, 2020) and HPLC methods (Gaware et al, 2015;Mohamed et al, 2019;Nalawade et al, 2020;Wattamwar et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Moussa

Mahrouse

Fawzy

2021

Biomedical Chromatography

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Gliflozins and gliptins represent two different pharmacological drug classes that exert different and potentially complementary glucose-lowering effect in patients with type II diabetes mellitus. A novel, selective, and sensitive HPLC method was developed for the determination of canagliflozin, empaglifozin, linagliptin, and metformin in pure form, in laboratory prepared mixtures, and in pharmaceutical dosage form. Experimental design optimization was applied by using Plackett-Burman and face-centered composite designs to achieve the best resolution with minimum experimental trials. Three significant variables affecting optimization, namely buffer pH, percentage of methanol, and percentage of acetonitrile, were studied. Chromatographic separation was achieved using an Agilent Eclipse C 8 column, and column temperature was kept at 45 C. The mobile phase was composed of dipotassium hydrogen phosphate buffer (0.05 M, adjusted to pH 6 using o-phosphoric acid):acetonitrile:methanol (50:25:25, v/v/v) at a flow rate of 1.5 mL/min. Sharp and wellresolved peaks of the cited drugs were obtained. The method was fully validated in terms of linearity, accuracy, precision, selectivity and robustness in agreement with the International Council of Harmonization (ICH) guidelines Q2 (R1). Satisfactory results were obtained by the analysis of tablets through applying the developed method. Therefore, it could be performed for the analysis of the cited drugs in quality control laboratories.

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Section: Introductionmentioning

confidence: 99%

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Moussa

Mahrouse

Fawzy

2021

Biomedical Chromatography

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“…Besides, similar methods have also been reported by other workers using the same extraction solvent (TBME) but differ in their % recovery and quantication limit. [9][10][11][12] In addition to traditional methods, commercially available SPE cartridges, such as Strata X polymeric sorbent, have been used by some workers [13][14][15] for the extraction of CNG from human plasma. Methanol and water were used as extraction solvents and the mean recovery of CNG was 77-98%.…”

Section: Sample Pretreatment Methodsmentioning

confidence: 99%

“…In addition to traditional methods, commercially available SPE cartridges, such as Strata X polymeric sorbent, have been used by some workers 13–15 for the extraction of CNG from human plasma. Methanol and water were used as extraction solvents and the mean recovery of CNG was 77–98%.…”

Section: Sample Pretreatment Methodsmentioning

confidence: 99%

Liquid chromatographic methods for the analysis of canagliflozin: concise overview and greener assessment

Haneef,

Khan

2023

Anal. Methods

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“…So, it differs from one drug to the other as follows: 20 mg/kg, 5 mg/kg, and 10 mg/kg for CANA, DAPA, and EMPA, respectively. Then animals were sacrificed according to the reported T max , 2 h for CANA and EMPA [23] and 1.5 h for DAPA [38]. Both plasma and brain samples were subjected to extraction before applying the proposed chromatographic method (Section 2.1).…”

Section: In Vivo Application and The Bbb Crossing Studymentioning

confidence: 99%

The potential off‐target neuroprotective effect of sister gliflozins suggests their repurposing despite not crossing the blood–brain barrier: From bioanalytical assay in rats into theory genesis

Hendy

Mowaka

Elkady

et al. 2023

J of Separation Science

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Gliflozins are successfully marketed antidiabetic agents with a reported neuroprotective effect, and this study tests their blood-brain barrier crossing ability. Henceforward, a computational hypothesis interpreting their effects was reasonable after failure to cross into the brain. A chromatographic bioassay for canagliflozin, dapagliflozin, and empagliflozin was developed, validated, and applied to the rat's and rat's plasma and brain. HPLC method robustness was tested over two levels using Design of Experiment on MINITAB. It is the first method for gliflozins' detection in rats' brain tissue. The method was applied on 18 rats and six for each drug. Concentrations in plasma were determined but neither of them was detected in brain at the described chromatographic conditions. A computational study for the three drugs was endorsing two techniques. First, ligand-based target fishing reveals possible targets for gliflozins. They showed an ability to bind with human equilibrative nucleoside transporter 1, a regulator of adenosine extracellularly. Second, a docking study was carried out on this protein receptor. Results showed perfect alignment with a minimum of one hydrogen bond. Dapagliflozin achieved the lowest energy score with two hocking hydrogen bonds. This is proposing gliflozins ability to regulate equilibrative nucleoside transporter 1 receptors in peripheries, elevating the centrally acting neuroprotective adenosine.

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Development of LC-MS/MS method for simultaneous determination of Canagliflozin and Metformin in human plasma and its pharmacokinetic application in Indian population under fast and fed conditions

Cited by 15 publications

References 24 publications

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

Liquid chromatographic methods for the analysis of canagliflozin: concise overview and greener assessment

The potential off‐target neuroprotective effect of sister gliflozins suggests their repurposing despite not crossing the blood–brain barrier: From bioanalytical assay in rats into theory genesis

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