Detection and structure elucidation of the new degradation impurities in the pharmaceutical formulations of ruxolitinib hydrobromide

Douša, Michal; Doubský, Jan; Gajdošová, Michaela; Tkadlecová, Marcela; Martinů, Tomáš; Jireš, Jakub

doi:10.1016/j.jpba.2020.113266

Cited by 6 publications

(2 citation statements)

References 14 publications

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“…The suggested UPLC technique is quicker and uses less solvent than previously reported HPLC methods since its total run time was just 3.4 min, as opposed to previous HPLC methods whose run time was typically varied from 7 to 15 min [3,4]. Additionally, the suggested UPLC approach has considerably fewer LOD (limit of detection) and LOQ (limit of quantification) values than HPLC methods previously described [5,6], indicating that it has superior sensitivity. The values can even be modified to a lower level to improve sensitivity and resolution.…”

Section: Discussionmentioning

confidence: 88%

Stability Indicating Analytical Method Development and Validation for the Estimation of Ruxolitinib in Bulk and Pharmaceutical Dosage Form Using Uplc

TABASSUM¹,

RIZWAN²

2023

Int J Pharm Pharm Sci

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Objective: To establish a simple and selective UPLC (Ultra-high Performance Liquid Chromatography) method for the determination of Ruxolitinib in tablet and bulk dosage forms. Methods: Chromatographic separation was achieved on a C8 column with the dimensions of (250×4.6m ID) 5 µm length; the mobile phase composition was a mixture of pH 6.2 with glacial acetic acid: Methanol: acetonitrile in the ratio of 40:30:30 was passed through the designated column with a flow rate of 1 ml per minute and the UV (Ultra Violet) detection was witnessed at 254 nm. Results: Linearity was observed in the range 50-150 µg/ml for Ruxolitinib (r² =0.9998) for drugs estimated by the proposed methods was in good agreement with the label claim. The % recovery of the drug was found to be between 98 and 102%. The drug was used for determining stability studies for acid, alkali, thermal, photolytic, and peroxide degradation. Conclusion: The method for determining Ruxolitinib was discovered to be simple, precise, accurate, and high resolution, with a shorter retention time, making it more acceptable and cost-effective for routine analysis.

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Section: Discussionmentioning

confidence: 88%

Stability Indicating Analytical Method Development and Validation for the Estimation of Ruxolitinib in Bulk and Pharmaceutical Dosage Form Using Uplc

TABASSUM¹,

RIZWAN²

2023

Int J Pharm Pharm Sci

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show abstract

“…The ruxolitinib content was determined using the stability-indicating high-performance liquid chromatography (HPLC) method previously published by from Douša et al [ 12 ]. Analysis was performed on an integral HPLC system Ultimate 3000 (Thermo-Fisher, Villebon-sur-Yvette, France) equipped with a diode array detector.…”

Section: Methodsmentioning

confidence: 99%

Physicochemical Stability Study of Oral Suspension Containing Ruxolitinib in Children with Steroid-Refractory Acute Graft-Versus-Host Disease

Hinterlang

Sebti

Cotteret

et al. 2022

The Scientific World Journal

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Ruxolitinib, used in children with steroid-refractory acute graft-versus-host (GVH) disease, is currently commercially available only as a tablet adult dosage. For the paediatric population, an oral liquid would be an adapted dosage formulation. The aim of this study was to develop ruxolitinib compounded oral suspensions at 2 mg/mL by using commercial tablets in available aqueous vehicle (Inorpha) and to measure its stability at both room temperature and under refrigeration. Chemical stability of suspensions containing ruxolitinib was evaluated for 60 days based on pH, degradation, and drug content. Physical stability of the drug suspension was evaluated by visual aspect and odour. The remaining ruxolitinib concentration of the suspension was at least 95% of the initial concentration after 60 days at both temperatures. The pH, colour, and odour of the suspensions throughout the study remained unchanged with respect to the initial time point.

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Ruxolitinib photodegradation mechanisms by theoretical and experimental chemistry

Secrétan

Schlatter

Cisternino

et al. 2021

Journal of Pharmaceutical and Biomedical Analysis

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Detection and structure elucidation of the new degradation impurities in the pharmaceutical formulations of ruxolitinib hydrobromide

Cited by 6 publications

References 14 publications

Stability Indicating Analytical Method Development and Validation for the Estimation of Ruxolitinib in Bulk and Pharmaceutical Dosage Form Using Uplc

Stability Indicating Analytical Method Development and Validation for the Estimation of Ruxolitinib in Bulk and Pharmaceutical Dosage Form Using Uplc

Physicochemical Stability Study of Oral Suspension Containing Ruxolitinib in Children with Steroid-Refractory Acute Graft-Versus-Host Disease

Ruxolitinib photodegradation mechanisms by theoretical and experimental chemistry

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