Identification and characterization of degradation products of dicloxacillin in bulk drug and pharmaceutical dosage forms

Impurity profiling of dicloxacillin sodium bulk drug and pharmaceutical dosage forms subjected to stability studies is evaluated. Of many impurities detected in HPLC analysis, three were not reported in the literature. The impurities have been identified by LC-MS; isolated by preparative HPLC; and c...

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Bibliographic Details
Published inJournal of pharmaceutical and biomedical analysis Vol. 43; no. 4; pp. 1470 - 1475
Main Authors Raj, T. Joseph Sunder, Bharati, C.H., Rao, K. Ranga, Rao, P. Satyanarayana, Narayan, G.K.A.S.S., Parikh, Kalpesh
Format Journal Article
LanguageEnglish
Published Amsterdam Elsevier B.V 12.03.2007
Elsevier Science
Subjects
Analysis
Analytical, structural and metabolic biochemistry
Anti-Bacterial Agents - analysis
Anti-Bacterial Agents - chemistry
Anti-Bacterial Agents - standards
Biological and medical sciences
Capsules
Characterization
Chromatography, Liquid
Degradation products
Dicloxacillin
Dicloxacillin - analysis
Dicloxacillin - chemistry
Dicloxacillin - standards
Drug Contamination
Drug Stability
Fundamental and applied biological sciences. Psychology
General pharmacology
Isolation
Magnetic Resonance Spectroscopy
Mass Spectrometry
Medical sciences
Molecular Structure
Pharmaceutical Preparations - analysis
Pharmaceutical Preparations - chemistry
Pharmaceutical Preparations - standards
Pharmacology. Drug treatments
Preparative HPLC
Spectrophotometry, Infrared
Characterization
Isolation
Dicloxacillin
Degradation products
Preparative HPLC
β-Lactams
Preparative chromatography
HPLC chromatography
Penicillin derivatives
Antibiotic
Bulk material
Dosage form
Qualitative analysis
Antibacterial agent
Degradation product
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Summary:Impurity profiling of dicloxacillin sodium bulk drug and pharmaceutical dosage forms subjected to stability studies is evaluated. Of many impurities detected in HPLC analysis, three were not reported in the literature. The impurities have been identified by LC-MS; isolated by preparative HPLC; and characterised by NMR, Mass spectroscopy and IR. Pure impurities obtained by isolation were co-injected with dicloxacillin sodium sample to confirm the retention times in HPLC. Structure elucidation of these degradation products by spectral data has been discussed in detail.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2006.10.004