Simultaneous determination of enantiomeric and organic impurities of vildagliptin on a cellulose tris(3-chloro-4-methylphenylcarbamate) column under revered-phase conditions

Papp, Lajos Attila; Hancu, Gabriel; Szabó, Zoltán‐István

doi:10.1016/j.jpba.2023.115495

Cited by 8 publications

(10 citation statements)

References 22 publications

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“…A variety of polysaccharide CSPs were applied to simultaneous chiral–achiral separations showing their versatility. The most often applied ones are the tris-(3,5-dimethylphenylcarbamate) derivatives of cellulose [ 16 , 17 , 18 , 21 , 24 , 28 , 46 , 55 ] and amylose [ 11 , 27 , 32 , 34 , 37 , 41 , 48 , 53 ], but other derivatives, such as amylose tris-(3-chlorophenylcarbamate) [ 42 ], cellulose tris-(3,5-dichlorophenylcarbamate) [ 22 , 38 , 41 ], cellulose tris(3-chloro-4-methylphenylcarbamate) [ 39 , 52 , 57 , 58 ], cellulose tris(4-methylbenzoate)-based [ 43 , 45 , 51 , 53 ], amylose tris(3-chloro-5-methylphenylcarbamate) [ 40 ], amylose tris[( S )-α-methylbenzylcarbamate], are also used [ 50 ]. In several cases, gradient elution was applied in combination with these columns [ 18 , 38 , 46 , 57 ].…”

Section: Discussionmentioning

confidence: 99%

“…It is worth noting that experimental design-based method optimization was successfully applied in several cases in combined enantio- and chemoselective separations, proving that statistical approaches based on the building of empirical models still can be employed independently from the nature of the retention mechanism [ 46 , 52 , 58 ]. Quality by design-compliant method development, as an almost mandatory approach in the current pharmaceutical analysis, including the application of statistical tools offered by experimental design methodologies, will probably have an accentuated presence soon in single-CSP-based chiral–achiral separations as well [ 96 , 97 ].…”

Section: Discussionmentioning

confidence: 99%

“…Method optimization consisted of an experimental design methodology in two steps: a screening design followed by an optimization one. The optimal conditions enabled the determination of all impurities with an at least 0.1% concentration relative to vildagliptin in 25 min [ 58 ]. A representative chromatogram obtained under optimized conditions is shown in Figure 2 .…”

Section: Enantio- and Chemoselective Methodsmentioning

confidence: 99%

“…(1—vildagliptin-amide, 2— R -vildagliptin, 3—vildagliptin, 4—vildagliptin-dimer, 5—vildagliptin-diketopiperazine, 6—dehydroxy-vildagliptin). Reprinted from Papp et al [ 58 ] with permission from Elsevier; ( b ) Chemical structure of vildagliptin and its impurities.…”

Section: Figurementioning

confidence: 99%

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Comprehensive Review on Chiral Stationary Phases in Single-Column Simultaneous Chiral–Achiral HPLC Separation Methods

Papp,

Szabó,

Hancu

et al. 2024

Molecules

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This comprehensive review explores the utilization of chiral stationary phases (CSPs) in the context of single-column simultaneous chiral–achiral high-performance liquid chromatography (HPLC) separation methods. While CSPs have traditionally been pivotal for enantioselective drug analysis, contemporary CSPs often exhibit notable chemoselective properties. Consequently, there is a discernible trend towards the development of methodologies that enable simultaneous enantio- and chemoselective separations utilizing a single CSP-based chromatographic column. This review provides an exhaustive overview of reported HPLC methods in this domain, with a focus on four major CSP types: cyclodextrin-, glycopeptide antibiotic-, protein-, and polysaccharide-based CSPs. This article delves into the diverse applications of CSPs, encompassing various chromatographic modes such as normal phase (NP), reverse phase (RP), and polar organic (PO). This review critically discusses method development, emphasizing the additional chemoselective separation mechanisms of CSPs. It also explores possibilities for method optimization and development, concluding with future perspectives on this evolving field. Despite the inherent challenges in understanding the retention mechanisms involved in chemoselective separations, this review highlights promising trends and anticipates a growing number of simultaneous enantio- and chemoselective methods in pharmaceutical analyses, pharmacokinetic studies, and environmental sample determinations.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Enantio- and Chemoselective Methodsmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

See 2 more Smart Citations

Comprehensive Review on Chiral Stationary Phases in Single-Column Simultaneous Chiral–Achiral HPLC Separation Methods

Papp,

Szabó,

Hancu

et al. 2024

Molecules

Self Cite

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“…These hormones are vital for maintaining normal blood glucose levels by increasing glucagon and insulin release in the pancreas. Several analytical techniques have been reported in the literature for the determination of vildagliptin, such as spectrophotometry [23][24][25][26][27], spectrofluorime-try [28], chromatography [29][30][31][32][33][34], capillary electrophoresis [35], and voltammetry [36]. Two potentiometric methods have been reported for the determination of vildagliptin.…”

Section: Introductionmentioning

confidence: 99%

Utilization of a TiO2–CuO Bimetallic/Polyaniline Nanocomposite as a Transducer in a Solid Contact Potentiometric Sensor for the Determination of Vildagliptin

Abdallah,

Ahmed,

Almaghrabi

et al. 2023

Polymers

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Current fundamental electrochemical research shows the potential of utilizing polymeric nanostructured materials as ion-to-electron transducers. In this paper, aniline was polymerized in the presence of TiO2 and CuO nanoparticles to yield a bimetallic/PANI nanocomposite. It was applied as a transducer in a carbon paste electrode for the potentiometric determination of vildagliptin in the presence of 18-crown-6-ether as a recognition element. The electrode’s potentiometric performance was studied according to the IUPAC guidelines. It exhibited a wide linearity range of 1 × 10−2 M to 1 × 10−8 M, remarkable sensitivity (LOD of 4.5 × 10−9 M), and a fast response time of 10 s ± 1.3. The sensor did not show any potential drift due to the absence of the water layer between the carbon paste and the metallic conductor. This endowed the sensor with high stability and a long lifetime, as 137 days passed without the need to change the carbon paste surface. The electrode was utilized for the determination of the concentration of vildagliptin in bulk, pharmaceutical tablets, and human plasma, with average recovery ranging from 97.65% to 100.03%.

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A systematic review on the clinical pharmacokinetics of vildagliptin in healthy and disease populations

Pasha,

Zamir,

Ashraf

et al. 2023

Expert Opinion on Drug Metabolism & Toxicology

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Simultaneous determination of enantiomeric and organic impurities of vildagliptin on a cellulose tris(3-chloro-4-methylphenylcarbamate) column under revered-phase conditions

Cited by 8 publications

References 22 publications

Comprehensive Review on Chiral Stationary Phases in Single-Column Simultaneous Chiral–Achiral HPLC Separation Methods

Comprehensive Review on Chiral Stationary Phases in Single-Column Simultaneous Chiral–Achiral HPLC Separation Methods

Utilization of a TiO2–CuO Bimetallic/Polyaniline Nanocomposite as a Transducer in a Solid Contact Potentiometric Sensor for the Determination of Vildagliptin

A systematic review on the clinical pharmacokinetics of vildagliptin in healthy and disease populations

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