Validation of different spectrophotometric methods for determination of vildagliptin and metformin in binary mixture

Farouk, Maha; Abdelaziz, Omar Y.; Ayad, Miriam F.; Tadros, Mariam M.

doi:10.1016/j.saa.2014.01.055

Cited by 36 publications

(16 citation statements)

References 20 publications

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“…The proposed DPV method is more sensitive than potentiometric method (1.0 × 10 -6 -1.0 × 10 -2 mol/L), 7 spectrophotometric methods: (6.038 × 10 -6 -7.25 × 10 -5 mol/L), 10 …”

Section: Determination Of Met In Bulkmentioning

confidence: 93%

“…1) is an orally administered antidiabetic that lowers glucose blood level by reducing hepatic glucose production and gluconeogenesis and by enhancing peripheral insulin sensitivity. [1][2][3] Published methods for the determination of MET are based on different techniques like capillary electrophoresis, 4,5 NMR spectrometry, 6 potentiometry, [7][8][9] spectrofluorimetry and spectrophotometry, [9][10][11][12][13][14][15][16][17][18][19][20] conductometry, 21,22 voltammetry, [23][24][25][26][27][28][29] IR spectrometry 30 and chromatography. [31][32][33][34][35][36][37][38][39] Although many of the reported methods are accurate and sensitive, they require the use of sophisticated equipment and expensive reagents.…”

Section: Introductionmentioning

confidence: 99%

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Voltammetric Assay of Metformin Hydrochloride Using Pyrogallol Modified Carbon Paste Electrode

Wm²,

Am³

2015

ACSi

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The electrooxidative behavior and determination of metformin hydrochloride, anti-hyperglycemic drug, on a pyrogallol modified carbon paste electrode were investigated using cyclic voltammetry and differential pulse voltammetry. Metformin hydrochloride shows an irreversible oxidation behavior over a wide interval of pH (Britton-Robinson buffers, pH 2-9). The peak current varied linearly in the range comprised between 8.0 × 10 -7 and 6.0 × 10 -6 mol/L with detection limit of 6.63 × 10 -8 mol/L and limit of quantification of 2.21 × 10 -7 mol/L. The method was proposed for the determination of metformin hydrochloride in dosage forms and urine.

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“…The proposed DPV method is more sensitive than potentiometric method (1.0 × 10 -6 -1.0 × 10 -2 mol/L), 7 spectrophotometric methods: (6.038 × 10 -6 -7.25 × 10 -5 mol/L), 10 …”

Section: Determination Of Met In Bulkmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Voltammetric Assay of Metformin Hydrochloride Using Pyrogallol Modified Carbon Paste Electrode

Wm²,

Am³

2015

ACSi

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“…Bratty et al developed a liquid chromatography (LC)-MS/MS method for the simultaneous determination of gliptins in human plasma. [16] Spectrophotometric methods to assess vildagliptin in bulk and pharmaceutical dosage forms have also been used [17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

Voltammetric determination of vildagliptin in a pharmaceutical formulation

Fadr¹,

Amro²,

Aoun³

2018

Trop. J. Pharm Res

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Purpose: To determine vildagliptin concentration in a pharmaceutical formulation using voltammetric analysis techniques, and optimize the parameters affecting the techniques. Method: Four types of voltammetry techniques, including cyclic voltammetry (CV), differential pulse voltammetry (DPV), square wave voltammetry (SWV), and linear sweep voltammetry (LSV), were employed to measure vildagliptin. Platinum (Pt) and glassy carbon (GC) were used as working electrodes, while KNO3 (1 M) and phosphate buffer (NaH2PO4/H3PO4) pH 6.8 were used to study optimal voltammetric analysis conditions. Results: CV results indicate that vildagliptin is electroactive and exhibits irreversible redox cycles while LSV results showed an oxidation peak current around 1.35 V that has high sensitivity and a linear standard regression line correlation coefficient of 0.9995. In addition, LSV results showed that vildagliptin has a lower limit of detection of ~ 0.241 mM and a limit of quantification of ~ 0.802 mM. Finally, the results show that vildagliptin has an acceptable level of recovery of 104.1 % and a relative standard deviation of 0.52 % for the commercially available vildagliptin tablets used in this study. Conclusion: The accuracy and precision of all applied voltammetric techniques for vildagliptin analysis are within accepted limits stipulated in pharmaceutical analysis quality control guidelines. The recommended method for vildagliptin analysis is LSV with Pt as the working electrode and KNO3 (1 M) as the supporting electrolyte.

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“…In our work, several synthetically modified, negatively charged α‐, β‐, and γ‐CD derivatives were applied as chiral selectors to separate the enantiomers of Vilda. To the best of our knowledge, no chiral method has been published so far on Vilda enantioseparation, only non‐chiral quantitative determinations in bulk and pharmaceutical formulations were reported . CD‐based chiral analysis of other DPP‐4 inhibitors, such as alogliptin and sitagliptin , has already been published by our group.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a cyclodextrin‐modified capillary electrophoresis method for the enantiomeric separation of vildagliptin enantiomers

et al. 2016

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The enantiomers of vildagliptin, an orally available and selective dipeptidyl-peptidase-4 inhibitor used for the treatment of type II diabetes, have been separated by CD-modified CZE, using uncoated fused-silica capillary. After screening 13 negatively charged CD derivatives as potential chiral selectors, sulfobutyl-ether-α-CD (SBE-α-CD) was selected for the enantioseparation. For the optimization, a factorial analysis study was performed by orthogonal experimental design. Six experimental factors were chosen as variable parameters: temperature, applied voltage, chiral selector and BGE concentrations, pH, and the parameters of the hydrodynamic injection. The optimized system still was not considered final as the second peak (S-enantiomer) migrated too close to the EOF, resulting in a potential inaccuracy during the determination of the chiral impurity. To fine-tune the method "one factor at a time" variation approach was applied. The final method (applying 15°C capillary temperature, 40 mbar × 4 s hydrodynamic injection, 25 kV voltage in 75 mM acetate-Tris buffer [pH 4.75] containing 20 mM SBE-α-CD as chiral selector) was validated according to the ICH guideline. RSD percentage of the resolution value, migration times, and corrected peak areas were below 5% during testing repeatability and intermediate precision. LOD and LOQ values were found to be 2.5 and 7.5 μg/mL, respectively. The method is considered linear in the 7.5-180 μg/mL range for the R-enantiomer. The robustness of the method was justified using Plackett-Burmann statistical experimental design.

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Validation of different spectrophotometric methods for determination of vildagliptin and metformin in binary mixture

Cited by 36 publications

References 20 publications

Voltammetric Assay of Metformin Hydrochloride Using Pyrogallol Modified Carbon Paste Electrode

Voltammetric Assay of Metformin Hydrochloride Using Pyrogallol Modified Carbon Paste Electrode

Voltammetric determination of vildagliptin in a pharmaceutical formulation

Development and validation of a cyclodextrin‐modified capillary electrophoresis method for the enantiomeric separation of vildagliptin enantiomers

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