Identification, isolation and characterization of a new degradation product in sultamicillin drug substance

Kumar, Vundavilli Jagadeesh; Gupta, P. Badarinadh; Kumar, Karunesh; Ray, Uttam Kumar; Sreenivasulu, B.; Kumar, G. S. Siva; Rao, K. Ranga; Sharma, Hemant; Mukkanti, K.

doi:10.1016/j.jpba.2010.09.016

Cited by 2 publications

(1 citation statement)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Molecular docking was performed using AutoDock Vina software, while molecular dynamics simulations were processed using YASARA software. [14,31]. A PR-FP batch sample was subjected to an informal stability study, in which the drug products were exposed to conditions of 30 °C/75% RH and 40 °C/75% RH for up to 8 weeks.…”

Section: Identifcation Of Impuritiesmentioning

confidence: 99%

Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation

Tjandrawinata,

Cahyana,

Nugroho

et al. 2024

Advances in Pharmacological and Pharmaceutical Sciences

View full text Add to dashboard Cite

Impurities compounds in any pharmaceutical product or drug substance are inevitable from a chemistry point of view. The quality and safety of a pharmaceutical product are also significantly affected by these impurities content; therefore, impurities need to be identified and characterized through the use of appropriate analytical methods. Pramipexole is a nonergot dopamine agonist used to treat various Parkinson’s disease symptoms. Two unknown impurities were detected from a pramipexole dihydrochloride solid dosage form. These impurities were identified and characterized using ultra-performance liquid chromatography coupled with high-resolution mass spectroscopy (UPLC-HRMS). These impurities were found to be enriched when mannitol existed in the formulation. The structure and mechanism involved in the existence of the impurities were proposed. Furthermore, observation of the binding affinity potential risk of these impurities to the pramipexole receptor has also been demonstrated through molecular docking and molecular dynamics simulation study. The binding energy result showed that pramipexole interaction with dopamine receptors D2 and D3 was higher than pramipexole mannose adduct and pramipexole ribose adduct.

show abstract

Section: Identifcation Of Impuritiesmentioning

confidence: 99%