Determination of d-Cycloserine Impurities in Pharmaceutical Dosage Forms: Comparison of the International Pharmacopoeia HPLC–UV Method and the DOSY NMR Method

Makuc, Damjan; Švab, Živa; Naumoska, Katerina; Plavec, Janez; Časar, Zdenko

doi:10.3390/molecules25071684

Cited by 4 publications

(1 citation statement)

References 26 publications

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“…The mode of action of Cycloserine against the bacteria is to inhibit bacterial wall synthesis by binding proteins. Some of the analytical methods reported for the assay of Cycloserine in the marketed form include spectrophotometry 10 , High-performance liquid chromatography (HPLC) 11, 12 , Capillary electrophoresis 13 , 14, 15 , HPTLC 15 and LC-MS/MS 16 . The current communication proposes a simple analytical procedure to quantify Cycloserine in pure and trade products using HPLC 11,12 .…”

Section: Fig 1: Cycloserinementioning

confidence: 99%

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2023

IJPSR

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Two simple and sensitive evulsions spectrophotometric methods have been described for the assay of Cycloserine either in pure form or in pharmaceutical formulations. The developed methods involve formation of coloured chloroform extractable ion -pair complexes of the drug with bromophenol blue (BPB) and bromo cresol green (BCG) in acidic medium. For two methods, the extracted complexes showed absorbance maxima at 408 and 419.5nm. Beer's law is obeyed in the concentration ranges 2.0-20 and 2.5-25μg/mL with BPB and BCG respectively. The effects of concentration of dye, pH and interference of recipients have been studied and optimized. The limit of detection and quantification has been determined for two methods. These two are very accurate methods of physical and instrumental mode of experiments. Two methods have been validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.INTRODUCTION: Cycloserine Fig. 1 is chemically known as 4-amino-1, 2-oxazolidin-3one with R configuration. It is an antibiotic produced by Streptomycin garyphalus or S -Orchidaceous and is used as part of a multi-drug regimen for the treatment of tuberculosis when resistance to, or toxicity from, primary drugs has developed. Cycloserine, sold under the brand name Seromycin and Cyserin, is a GABA transaminase inhibitor and an antibiotic, used to treat tuberculosis 1, 2 . Specifically it is used, along with other antituberculosis medications, for active drug resistant tuberculosis.

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Section: Fig 1: Cycloserinementioning

confidence: 99%

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2023

IJPSR

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A battery of tandem mass spectrometry assays with stable isotope-dilution for the quantification of 15 anti-tuberculosis drugs and two metabolites in patients with susceptible-, multidrug-resistant- and extensively drug-resistant tuberculosis

Mercier

Desfontaine

Cruchon

et al. 2022

Journal of Chromatography B

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Applications of Pulsed Field Gradient Nuclear Magnetic Resonance to Late-stage Pharmaceutical and Biopharmaceutical Development and Deployment

Mantle

2024

Magnetic Resonance and Its Applications in Drug Formulation and Delivery

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Pulsed field gradient nuclear magnetic resonance (PFG-NMR) is a powerful methodology that encodes the microscopic molecular displacements of a substance. Subsequent analysis of the PFG-NMR data then recovers the substance’s molecular self-diffusivity, D, in units of m2 s−1. This chapter is primarily divided into two sections: the first section elucidates the background and theory behind the PFG-NMR experiment and describes mathematically how the molecular self-diffusion coefficient, D, is extracted from PFG-NMR datasets. The latter half of the first section demonstrates how numerical simulations of PFG-NMR data serve as valuable tools to illustrate the effects observed in real PFG-NMR datasets. These effects include multiple-component molecular diffusion, diffusive molecular exchange, and restricted diffusion. The second half of the chapter focuses on the diverse applications of PFG-NMR in late-stage pharmaceutical and biopharmaceutical development and deployment research. It emphasizes specific research aimed at enhancing our scientific comprehension of the principal challenges and questions faced by the pharmaceutical and biopharmaceutical industries.

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Determination of d-Cycloserine Impurities in Pharmaceutical Dosage Forms: Comparison of the International Pharmacopoeia HPLC–UV Method and the DOSY NMR Method

Cited by 4 publications

References 26 publications

Untitled

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A battery of tandem mass spectrometry assays with stable isotope-dilution for the quantification of 15 anti-tuberculosis drugs and two metabolites in patients with susceptible-, multidrug-resistant- and extensively drug-resistant tuberculosis

Applications of Pulsed Field Gradient Nuclear Magnetic Resonance to Late-stage Pharmaceutical and Biopharmaceutical Development and Deployment

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