Development and validation of a Sensitive bioanalytical method for the quantitative estimation of Pantoprazole in human plasma samples by LC–MS/MS: Application to bioequivalence study

Challa, B.R.; Boddu, Sai H. S.; Awen, Bahlul Z.; Chandu, Babu Rao; Bannoth, Chandrasekhar Kothapalli; Mukkanti, K.; Kanala, Kanchanamala; Shaik, Rihana Parveen

doi:10.1016/j.jchromb.2010.03.049

Cited by 24 publications

(13 citation statements)

References 12 publications

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“…MK blocks CysLT 1 , in lungs and bronchial tubes, reducing bronchoconstriction. It was the first leukotriene antagonist receptor granted for its use in children by FDA and it has been widely employed in the last years .…”

Section: Introductionmentioning

confidence: 99%

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Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product

et al. 2016

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A stereoselective CD-MEKC system has been developed for the quality control of Montelukast (MK), commercialized as a pure enantiomer. The proposed method is the first one that allows the simultaneous determination of MK, its enantiomeric form, diasteroisomers and its main degradation compound (MK sulphoxide). CD-MEKC system is composed of 10 mM SDS, 10 mM sulfobutylether-␤-CD, 10 mM TM-␤-CD, and 20 mM borate buffer at pH 9.0. Combination of these two CDs allows high baseline enantioresolution between MK and its enantiomeric impurity, but also, between the diasteroisomeric forms. Moreover, a multivariate design was applied to optimize operational parameters. The method was designed to meet with requirements of the official pharmacopoeias and fully validated according to international guidelines. Linearity of MK was demonstrated in the range from 10.0 to 100.0 g/mL (r 2 = 0.9908) with a LOD and LOQ of 0.30 and 0.90 g/mL, respectively. Intra and interday precision were evaluated and RSD values were below 2%, and also, accuracy expressed as percentage of recovery was in a range from 99.0 to 101.9 for the three assayed levels. The method allows determining 0.02% w/w of the enantiomeric and diasteroisomeric impurities, and 0.01% w/w of MK sulphoxide. Robustness was evaluated by a Plackett and Burman design. Finally, the CD-MEKC system was successfully applied to the determination of related substances in MK bulk drug and its quantification in two pediatric pharmaceutical dosage forms.

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Section: Introductionmentioning

confidence: 99%

“…Moreover, several methods for the quantification of MK in pharmaceutical dosage forms, stability and pharmacokinetics studies have been developed. Most of them describe HPLC methods coupled to UV or MS detector . Nevertheless, so far only one capillary electrophoretic method has been reported .…”

Section: Introductionmentioning

confidence: 99%

Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product

et al. 2016

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“…1 Analytical determination of pantoprazole in pharmaceutical formulations and in biological media is routinely based on chromatographic [2][3][4][5][6][7][8][9][10][11] and spectroscopic methods. [12][13][14][15] Considering the electro-oxidation ability of pantoprazole probably due to the presence of an amino group at the benzimidazole ring of its structure, 16 developing voltammetric methods should be a better approach to its analytical determination because it is well known that these methods can overcome some of the problems associated to the chromatographic or spectroscopic methods.…”

Section: Introductionmentioning

confidence: 99%

Anodized Edge-plane pyrolytic graphite for electroanalysis of pantoprazole in tablet dosage forms and human urine samples

Hadi

Ehsani

2016

S.Afr.j.chem.

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Electroanalytical parameters of different graphitic carbon-based electrode materials were compared to select the best one for the pantoprazole electroanalysis. Such parameters include sensitivity, repeatability, residual background current, and signal-tobackground current ratio of the analytical response and such electrodes include conventional carbon-based electrodes such as glassy carbon (GC), carbon paste, edge-plane pyrolytic graphite (EPPG), and basal-plane pyrolytic graphite electrodes and film-coated modified GC electrodes with graphitic carbon-based materials such as carbon nanotube, nanographene, carbon black and graphite powder. The EPPG electrode, after applying a simple electrochemical anodization, showed more acceptable analytical performances compared with the other electrodes. Raman spectroscopy was employed to study the surface structural changes that occurred dring the anodic activation. Calibration plot with a good linearity was obtained in the concentration range of 0.2-25 and 0.02-8.5 µM, and the detection limit was estimated to be 0.055 and 0.0041 µM using cyclic voltammetry and differential pulse voltammetry techniques, respectively. Finally, the electrochemically activated EPPG electrode was used successfully for the determination of pantoprazole in tablet dosage forms and human urine samples with satisfactory results. KEYWORDSEdge-plane pyrolytic graphite, graphitic carbon-based electrodes, anodic activation, pantoprazole electroanalysis, nanographene, carbon nanotube.

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“…Many achiral methods for determination of pantoprazole in serum or plasma in different species including rat, dog, and human have been reported. [9][10][11] The sample preparation methods included protein precipitation, 10 , liquid-liquid extraction, 12,13 and solid-phase extraction. 14 In addition, several methods have been published for the determination of pantoprazole enantiomers in vitro or in vivo, including two-dimensional achiral-chiral chromatography coupled with ion trap mass spectrometry, 15 capillary electrophoresis method, 16 high-performance liquid chromatography (HPLC)-UV using chiral mobile phase additive, 17 HPLC-UV with teicoplanin-bonded or cellulose-based chiral stationary phase and ligand exchange chiral stationary phase, [18][19][20][21][22] and HPLC-MS (mass spectrometry) with an Ultron ES-OVM column.…”

mentioning

confidence: 99%

High‐Throughput Chiral LC–MS/MS Method Using Overlapping Injection Mode for the Determination of Pantoprazole Enantiomers in Human Plasma with Application to Pharmacokinetic Study

Jiang

Wang

et al. 2016

Chirality

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A sensitive and high-throughput chiral liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of R-pantoprazole and S-pantoprazole in human plasma. Sample extraction was carried out by using ethyl acetate liquid-liquid extraction in 96-well plate format. The separation of pantoprazole enantiomers was performed on a CHIRALCEL OJ-RH column and an overlapping injection mode was used to achieve a run time of 5.0 min/sample. The mobile phase consisted of 1) 10 mM ammonium acetate in methanol: acetonitrile (1:1, v/v) and 2) 20 mM ammonium acetate in water. Isocratic elution was used with flow rate at 500 μL/min. The enantiomers were quantified on a triple-quadrupole mass spectrometer under multiple reaction monitoring (MRM) mode with m/z 382.1/230.0 for pantoprazole and m/z 388.4/230.1 for pantoprazole-d7. Linearity from 20.0 to 5000 ng/mL was established for each enantiomer (r(2) > 0.99). Extraction recovery ranged from 91.7% to 96.4% for R-pantoprazole and from 92.5% to 96.5% for S-pantoprazole and the IS-normalized matrix factor was 0.98 to 1.07 for R-pantoprazole and S-pantoprazole, respectively. The method was demonstrated with acceptable accuracy, precision, selectivity, and stability and the method was applied to support a pharmacokinetic study of a phase I clinical trial of racemic pantoprazole in healthy Chinese subjects. Chirality 28:569-575, 2016. © 2016 Wiley Periodicals, Inc.

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Development and validation of a Sensitive bioanalytical method for the quantitative estimation of Pantoprazole in human plasma samples by LC–MS/MS: Application to bioequivalence study

Cited by 24 publications

References 12 publications

Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product

Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product

Anodized Edge-plane pyrolytic graphite for electroanalysis of pantoprazole in tablet dosage forms and human urine samples

High‐Throughput Chiral LC–MS/MS Method Using Overlapping Injection Mode for the Determination of Pantoprazole Enantiomers in Human Plasma with Application to Pharmacokinetic Study

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