Simultaneous Chemo/Enantioseparation and Assay of R-(+)-Rabeprazole and Related Impurities in Pharmaceutical Formulations

Balamurugan, P.; Basha, K. Anver; Jayachandran, Jeenet; Gangrade, Manish; Parthiban, P.

doi:10.1007/s10337-015-2968-x

Cited by 5 publications

(4 citation statements)

References 31 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%

“…Additionally, the chemical structures of two unknown impurities of the drug were elucidated based on their ESI-MS/MS fragmentation patterns. The final, validated LC-UV method could determine the enantiomeric and three other organic impurities of rabeprazole at 0.02–0.03% concentrations relative to rabeprazole [ 38 ].…”

Section: Enantio- and Chemoselective Methodsmentioning

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: Enantio- and Chemoselective Methodsmentioning

confidence: 99%

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

Papp,

Szabó,

Hancu

et al. 2024

Molecules

View full text Add to dashboard Cite

show abstract

“…have been determinated in environmental or food samples (soil, natural waters, fruits, vegetables, etc.). Pharmaceutical compounds recognized as potential anti-carcinogen agents [44,45,56,92,64], α-and β-adrenergic receptor blockers [51,92,59,[65][66][67][68]60], nonsteroidal anti-inflammatory drugs [38], antihistamines [92,74], proton pump inhibitors [50,94,73,79,81,88,96,76], retroviral drugs [55,84], antihyperglycemic drugs [83], antihelminthic agents [40,57], anti-hypertensive drugs [41,53,85], L-type calcium channel [72,89], broad-spectrum antimicrobials [95,70], nootropic drugs [90,91], anticoagulant drugs [69], etc. have also been determined, especially in commercial products or biological samples (pharmaceutical formulations, human urine, human or animal blood, human plasma, animal serum, etc.).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

State-of-the-art and recent developments of immobilized polysaccharide-based chiral stationary phases for enantioseparations by high-performance liquid chromatography (2013–2017)

Padró

Keunchkarian

2018

Microchemical Journal

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Please cite this article as: Juan M. Padró, Sonia Keunchkarian , State-of-the-art and recent developments of immobilized polysaccharide-based chiral stationary phases for enantioseparations by high-performance liquid chromatography (2013)(2014)(2015)(2016)(2017). AbstractPolysaccharide-based chiral stationary phases have been recognized as one of the most powerful ones for high performance liquid chromatography (HPLC) separations of chiral compounds in analytical and also in preparative scale.Immobilized polysaccharide-based chiral stationary phases constitute a remarkable achievement due to their stable nature on working with standard or common solvents and also with those prohibited for using with coated phases.This review is mainly focused on the i. applications of these chiral stationary phases in numerous fields of HPLC separations; ii. comparative aspects between immobilized vs. coated polysaccharide-derived phases, and iii. revision of several theoretical studies such as enantiorecognition mechanism, mobile phase composition and column temperature effects.

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“…In particular, assay estimation, evaluation, and control of impurities in drug substances/products is important. An increasing number of publications on development of analytical methods for rabeprazole analysis show the significance of impurities of rabeprazole . Further, several analytical techniques are available in pharmaceutical companies such as GC‐ECD and HPLC‐PDA, which must be employed as the standard techniques primarily in the GTIs analysis.…”

Section: Introductionmentioning

confidence: 99%

A simple, sensitive, and straightforward LC–MS approach for rapid analysis of three potential genotoxic impurities in rabeprazole formulations

Yenugu

Reddy

Madhavi

2018

J of Separation Science

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In the present study, a sensitive and fully validated liquid chromatography with mass spectrometry method was developed for the quantification of three potential genotoxic impurities in rabeprazole drug substance. The separation was achieved on Symmetry C18 column (100 × 4.6 mm, 3.5 μm) using 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at 0.5 mL/min flow rate. Triple quadrupole mass detection with electrospray ionization was operated in selected ion recording mode for the quantification of impurities. The calibration curves were demonstrated good linearity over the concentration range of 1.0-4.5 ppm for O-phenylenediamine, 1.8-4.5 ppm for 4-nitrolutidine-N-oxide and 1.0-4.5 ppm for benzyltriethylammonium chloride with respect to 10 mg/mL of rabeprazole. The correlation coefficient obtained in each case was >0.998. The recoveries were found satisfactory over the range between 94.22 and 106.84% for all selected impurities. The method validation was carried out following International Conference on Harmonization guidelines, from which the developed method was able to quantitate the impurities at 1.0 ppm for O-phenylenediamine, 1.8 ppm for 4-nitrolutidine-N-oxide and 1.0 ppm for benzyltriethylammonium chloride. Furthermore, the proposed method was successfully evaluated for the determination of selected impurities from bulk drug and formulation samples of rabeprazole within the acceptable limits.

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Simultaneous Chemo/Enantioseparation and Assay of R-(+)-Rabeprazole and Related Impurities in Pharmaceutical Formulations

Cited by 5 publications

References 31 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

State-of-the-art and recent developments of immobilized polysaccharide-based chiral stationary phases for enantioseparations by high-performance liquid chromatography (2013–2017)

A simple, sensitive, and straightforward LC–MS approach for rapid analysis of three potential genotoxic impurities in rabeprazole formulations

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