LC–MS/MS and NMR characterization of forced degradation products of mirabegron

Parsha, Swetha; Kumar, Yogesh; Ravichander, M.; Prakash, Lakkireddy; Sudharani, B.

doi:10.1080/10826076.2016.1144201

Cited by 12 publications

(8 citation statements)

References 14 publications

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“…The resulting degradation products (DPs) have the potential to affect the safety and efficacy of drugs, possibly leading to adverse effects and toxicity 18–20 . Therefore, it is essential to identify degradation pathways when developing formulation strategies and stability‐indicating methods 21,22 . However, there is currently no systematic study reported on the degradation pathway of brivaracetam, 23,24 highlighting the need for further investigation.…”

Section: Introductionmentioning

confidence: 99%

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Identification of degradation products of brivaracetam using liquid chromatography quadrupole time‐of‐flight tandem mass spectrometry: Degradation pathway elucidation

Xu,

Ning,

et al. 2023

Rapid Comm Mass Spectrometry

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RationalePyrrolidone‐based drugs find widespread use in treating conditions such as epilepsy and Alzheimer's disease, and in various other medical applications. Brivaracetam, the latest generation of pyrrolidone drugs, has exhibited significant promise owing to chemical structure modifications. Its affinity to the SV2A receptor is double that of the previous‐generation drug, levetiracetam. Consequently, brivaracetam holds substantial potential for diverse applications. As a novel drug not yet included in the pharmacopeias of developed nations, comprehensive analysis and research are necessary to guarantee its safe utilization in clinical settings.MethodsA liquid chromatography quadrupole time‐of‐flight tandem mass spectrometry (LC/QTOFMS) method has been developed to effectively separate, identify and characterize both the degradation products and process‐related substances of brivaracetam. Stress testing of the sample was carried out following the guidelines outlined in ICH Q1A(R2). The structures of these impurities were identified through positive electrospray ionization QTOF high‐resolution MS and NMR spectroscopy. Additionally, the formation mechanism of each degradation product is thoroughly discussed.ResultsUnder the analytical conditions outlined in this paper, brivaracetam and its degradation products were effectively separated. Thirteen degradation products were detected and characterized, shedding light on their origins and degradation pathways. Among these, three degradation products align with previously reported impurities, and two unreported degradation products were synthesized and confirmed through NMR spectroscopy. The stress testing results revealed the instability of brivaracetam under acidic, alkaline, oxidative and thermal stress conditions, while it exhibited relative stability under photolytic stress conditions.ConclusionThe study developed an analytical method for brivaracetam that enabled the effective detection and separation of brivaracetam and its 13 degradation products. This method addresses a gap in both current domestic and foreign drug standards. The structures of all the major degradation products were characterized by high‐resolution LC/QTOFMS, which is essential for quality control during the drug production process, stability evaluation and the establishment of proper storage conditions.

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Section: Introductionmentioning

confidence: 99%

“…[18][19][20] Therefore, it is essential to identify degradation pathways when developing formulation strategies and stability-indicating methods. 21,22 However, there is currently no systematic study reported on the degradation pathway of brivaracetam, 23,24 highlighting the need for further investigation.…”

Section: Introductionmentioning

confidence: 99%

Identification of degradation products of brivaracetam using liquid chromatography quadrupole time‐of‐flight tandem mass spectrometry: Degradation pathway elucidation

Xu,

Ning,

et al. 2023

Rapid Comm Mass Spectrometry

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“…LC-MS/MS is method for determination of Mirabegron in biological fluids and pharmaceutical dosage forms. [14][15][16] Hence there is a need to develop an RP-HPLC method for the estimation of Mirabegron in Extended-Release tablets. The present work reveals that RP-HPLC method is a simple, precise, accurate, rapid and economical for the assay of Mirabegron in Extended-Release tablets.…”

Section: Introductionmentioning

confidence: 99%

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Ramazani

Rezaei

2018

JMCS

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“…Chemical name for the tetrabenazine is a 3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one [7][8]2] with molecular formula C19H27NO3 and molecular weight 317.42. Various methods in the literature involve a determination of tetrabenazine by HPLC, LC/MS, pharmacokinetics, pharmacodynamics, UV [8].…”

Section: Introductionmentioning

confidence: 99%

“…The hyperkinetic movement disorders include neurological disease characterized by abnormal involuntary movement, such as Chorea associated with Huntington's disease. On August 2008 FDA approved the use of tetrabenazine to treat Chorea associated with Huntington's disease, the first in the USA [1][2]. Tetrabenazine is a benzoquinoline pharmacophore that selectively depletes monoamines and improves hyperkinetic movement symptoms [3].…”

Section: Introductionmentioning

confidence: 99%

An Applicable Method for the Estimation of Tetrabenazine by Simple RP-HPLC in Tablet Dosage Form

2017

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The aim of this work was to develop and validate the assay test for Tetrabenazine in the pharmaceutical dosage forms by HPLC. The assay method by HPLC was found to be linear in the concentration range of 20 to 100 µg/mL. The mobile phase was composed of acetonitrile and buffer pH: 6.8 potassium dihydrogen phosphate (60:40 v/v) the flow rate of 1 mL/min using UV detection at 215 nm. The results of the analysis were validated by recovery studies. The percentage recovery method was found to be 99.33-100.87%. The LOD and LOQ were found to 0.04 μg/mL and 0.15 μg/mL. All the parameters of validation were in the acceptable range. This developed method was successfully applied to estimate the amount of Tetrabenazine in the tablets.

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LC–MS/MS and NMR characterization of forced degradation products of mirabegron

Cited by 12 publications

References 14 publications

Identification of degradation products of brivaracetam using liquid chromatography quadrupole time‐of‐flight tandem mass spectrometry: Degradation pathway elucidation

Identification of degradation products of brivaracetam using liquid chromatography quadrupole time‐of‐flight tandem mass spectrometry: Degradation pathway elucidation

Untitled

An Applicable Method for the Estimation of Tetrabenazine by Simple RP-HPLC in Tablet Dosage Form

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