Impurity Profiling of Baclofen Using Gradient HPLC–UV Method

Leistner, Adrian; Holzgrabe, Ulrike

doi:10.1007/s10337-021-04079-y

Cited by 3 publications

(1 citation statement)

References 15 publications

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“…Стоит отметить, что подобные обстоятельства замены режима анализа были описаны в литературе. Так Leistner & Holzgrabe (2021) при анализе примесей к субстанции баклофена использовали градиентный режим, поскольку существующие примеси для данного вещества представлены труднорастворимыми цвиттер-ионами [32] Аналогично анализировались 11 примесей субстанции ивабрадина [33] и комбинации фармакологически активных соединений парацетамола и метионина [34].…”

Section: результаты и обсуждение разработка методики количественного определения фексофенадина гидрохлорида и аммония глицирризината при unclassified

Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

Ларский

Позднякова

Хаджиева

et al. 2021

Farm. farmakol. (Pâtigorsk)

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Intranasal administration of H1-histamine receptor blockers may be a promising approach to the treatment of allergic rhinitis. Earlier, an original composition of a nasal spray containing fexofenadine hydrochloride and ammonium glycyrrhizinate and demonstrating a high level of therapeutic efficacy, was developed.The aim of the study was to develop and validate a method of the quantitative determination of active pharmaceutical ingredients fexofenadine hydrochloride and ammonium glycyrrhizinate in a spray for intranasal administration.Materials and methods. During the development and validation of the method of the fexofenadine hydrochloride and ammonium glycyrrhizinate quantitative determination in a nasal spray, the method of high performance liquid chromatography was used: a Dionex Ultimate 3000 UV chromatograph with a Luna C18 column (2) containing octadecylsilicagel with a 5 μm grain size as a sorbent. The analysis and validation procedures were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, the XIVth edition.Results. The study showed that for the simultaneous quantitative determination of fexofenadine hydrochloride and ammonium glycyrrhizinate, the optimal elution regime is a gradient mode with a mobile phase containing 50 mmol/L potassium dihydrogen phosphate solution with methanol (45:55), which ensured the separation of the components in the 20 minutes interval. The validation procedures showed that the developed methodology correspond to all the criteria of validity in terms of the following indicators: correctness, precision, specificity and linearity in the analytical area.Conclusion. The obtained results indicate the possibility of using the method of high-performance liquid chromatography in a gradient elution mode with a mobile phase of the composition of a 50 mmol/L solution of potassium dihydrogen phosphate with methanol (45:55) for the simultaneous quantitative determination of active pharmaceutical ingredients – fexofenadine hydrochloride and ammonium glycyrrhizinate as parts of a promising nasal spray for the allergic rhinitis treatment.

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Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

Ларский

Позднякова

Хаджиева

et al. 2021

Farm. farmakol. (Pâtigorsk)

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A Novel HPLC Method for Quality Inspection of NRK Biosynthesized β-Nicotinamide Mononucleotide

Zhou

et al. 2023

Journal of Chromatographic Science

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β-nicotinamide mononucleotide (NMN) has a good effect on delaying aging, repairing DNA and ameliorating metabolic disease. Biosynthesis with nicotinamide riboside kinase (NRK) takes a large part in NMN manufacture, but there is no available NMN quality standard and analytical method at present. In this study, we developed a specific high-performance liquid chromatography method for the assessment of NMN-related substances, including NMN and its potential impurities from NRK biological production and storage. Forced degradation study was performed under acid, base, oxidative, photolytic and thermal conditions. The separation of related substances was achieved on an Elite Hypersil ODS column using phosphate buffer–methanol gradient at a flow rate of 1.0 mL/min. The detection wavelength was maintained at 260 nm. The resolutions among all related substances were better than 1.5. Significant degradation was observed in basic and thermal conditions. All related substances showed good linearity with a coefficient of determination (R2) higher than 0.999. The accuracy values of all related substances were between 91.2% and 108.6%. Therefore, the validated analytical method is appropriate for inspecting the quality of NMN in its NRK biosynthetic manufacture and storage, thus further helping to unify NMN quality standards and facilitate related studies on NMN.

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An Overview of Analytical Methods for the Identification and Quantification of Baclofen

Oshiro

Silva

et al. 2023

CPA

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Background: Baclofen is a potent antispasmodic agent, acting as an analgesic and central skeletal muscle relaxant. It is a GABA-B analog, and is widely used for the treatment of spasticity. Due to its therapeutic importance, various analytical techniques are used in the pharmaceutical industry and research to determine, identify, and characterize baclofen in bulk material, biological fluids, and pharmaceutical forms. Objective: This review aimed to collect information on reported analytical techniques commonly used to identify and quantify baclofen in pharmaceutical forms and biological samples. Methods: The authors explored various authenticated scientific journals using these descriptors: highperformance liquid chromatography, liquid chromatography-tandem mass spectrometry, capillary electrophoresis, differential scanning calorimetry, Fourier transform infrared spectroscopy, ultravioletvisible spectroscopy, near-infrared spectroscopy, nuclear magnetic resonance, potentiometry, and Xray diffraction. Results: Quantification of the drug by all the methods evaluated in the review was possible. There were 73 articles reviewed, of which 26 used HPLC for baclofen quantification; the least used was near infrared spectroscopy and potentiometry, both with one article identified. Conclusion: This review has shed light on a wide variety of analytical methods that can be used to quantify and identify baclofen. The knowledge provided by the use of these analytical methods makes this document an important tool for developing pharmaceutical formulations containing baclofen.

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Impurity Profiling of Baclofen Using Gradient HPLC–UV Method

Cited by 3 publications

References 15 publications

Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

Development and Validation of Methods for Quantitative Determination of Active Pharmaceutical Substances in Nasal Spray

A Novel HPLC Method for Quality Inspection of NRK Biosynthesized β-Nicotinamide Mononucleotide

An Overview of Analytical Methods for the Identification and Quantification of Baclofen

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