Validated method for determination of bromopride in human plasma by liquid chromatography–electrospray tandem mass spectrometry: application to the bioequivalence study

Nazare, P.; Massaroti, P.; Duarte, Luciana Fernandes; Campos, Daniel Rossi de; Marchioretto, M. A. M.; Bernasconi, G.; Calafatti, Silvana A.; Barros, Fábio Alessandro Proença; Meurer, Eduardo C.; Pedrazzoli, José; Moraes, Luiz Alberto Beraldo

doi:10.1002/jms.898

Cited by 9 publications

(4 citation statements)

References 14 publications

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“…Procainamide was used as an internal standard. The ESI was operated as described by Nazare et al (27) in the positive (ES+) and the multiple reaction monitoring mode; analysis was measured at m/z 344.20 > 271.00 for BPD and m/z 236.30 > 163.10 for procainamide.…”

Section: In Vivo Studymentioning

confidence: 99%

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

Giovani¹,

Silva²,

Volpato³

et al. 2015

Dissolution Technol.

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The aim of this study was the development of a dissolution test with IVIVC for extended-release bromopride (BPD) pellets using bioavailability data. BPD is a Biopharmaceutics Classification System Class 2 drug, and its absorption is primarily limited by its dissolution rate. Despite this, there are no reports describing a dissolution test for BPD dosage forms. The dissolution medium was selected based upon the sink condition and the gastrointestinal pH. Furthermore, USP Apparatus 1 and 3 were tested, and the dissolution method was compared with that outlined by the manufacturer of the reference drug. Deconvolution by the Wagner-Nelson method was used to obtain the fraction of drug absorbed. The dissolution test that yielded IVIVC for both the fasted and fed states (R 2 > 0.97) and also the discriminative power used Apparatus 1 at 75 rpm in 900 mL of HCl. The dissolution medium (900 mL PBS pH 7.2) was changed after 1 h. Additionally, quantitative analysis was successfully validated by UV absorption (273 nm). Drug release is controlled by the pellet coating and by BPD solubility. The Higuchi release kinetics model best describes the dissolution of commercial BPD pellets batches.

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Section: In Vivo Studymentioning

confidence: 99%

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

Giovani¹,

Silva²,

Volpato³

et al. 2015

Dissolution Technol.

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“…Moreover, as a consequence of the mass selectivity, it was expected that the time required for method development and sample turnover could be significantly reduce. However, ion suppression by the matrix requires that most of the biological matrix constituents are removed before LC-MS-MS analysis, making sample preparation a time-consuming step in the development of LC-MS-MS procedures [18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

Determination of Quinine and Doxycycline in Rat Plasma by LC–MS–MS: Application to a Pharmacokinetic Study

et al. 2011

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A fast, sensitive, and specific LC-MS-MS method for determination of quinine (QN) and doxycycline (DOX) in rat plasma has been developed and validated. QN, DOX, and cimetidine (internal standard, IS) were extracted from the plasma by protein precipitation. The compounds were separated on a C 18 column with methanol-0.1% aqueous formic acid 70:30 (v/v) as mobile phase at a flow rate of 0.5 mL min -1 (split 1:3). Detection was by positive electrospray ionization (ESI?) in multiple reaction monitoring (MRM) mode, monitoring the transitions 325.0 ? 307.0, 445.0 ? 428.1, and 252.8 ? 159.0, for QN, DOX, and IS, respectively. The analysis was carried out in 2.0 min and the method was linear in the plasma concentration range 5-5,000 ng mL -1 . The mean extraction recoveries for QN, DOX, and IS from plasma were 89.4, 90.5, and 86.3%, respectively. The method was validated for linearity, precision, accuracy, specificity, and stability; the results obtained were within the acceptable range. The proposed method was successfully applied to the determination of QN and DOX in rat plasma samples to support pharmacokinetic studies.

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“…1 Some techniques have been used to determine bromopride in different biological matrices. Such methods include liquid chromatography-electrospray tandem mass spectrometry, 2 high-performance liquid chromatography with UV detection, [3][4][5] thin-layer chromatography and gas chromatography. 6 The pharmacopoeia does not present methods for the assay of bromopride in oral and injectable solutions.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of RP-LC and uv spectrophotometric methods to assay bromopride in oral and injectable solutions

Fontana¹,

Hurtado²,

Wrasse³

et al. 2010

Quím. Nova

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Recebido em 26/2/09; aceito em 15/6/09; publicado na web em 25/11/09 A reversed-phase liquid chromatographic (LC) and ultraviolet (UV) spectrophotometric methods were developed and validated for the assay of bromopride in oral and injectable solutions. The methods were validated according to ICH guideline. Both methods were linear in the range between 5-25 mg mL -1 (y = 41837x -5103.4, r = 0.9996 and y = 0.0284x -0.0351, r = 1, respectively). The statistical analysis showed no significant difference between the results obtained by the two methods. The proposed methods were found to be simple, rapid, precise, accurate, and sensitive. The LC and UV methods can be used in the routine quantitative analysis of bromopride in oral and injectable solutions.

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Validated method for determination of bromopride in human plasma by liquid chromatography–electrospray tandem mass spectrometry: application to the bioequivalence study

Cited by 9 publications

References 14 publications

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

Determination of Quinine and Doxycycline in Rat Plasma by LC–MS–MS: Application to a Pharmacokinetic Study

Development and validation of RP-LC and uv spectrophotometric methods to assay bromopride in oral and injectable solutions

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