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 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.
Raj
T Joseph Sunder
TJ
APL Research Centre, A Division of Aurobindo Pharma Ltd., 313, Bachupally, Quthubullapur, Hyderabad 500072, India.
Bharati
C H
CH
Rao
K Ranga
KR
Rao
P Satyanarayana
PS
Narayan
G K A S S
GK
Parikh
Kalpesh
K
D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D002214:Capsules; D002853:Chromatography, Liquid; D004009:Dicloxacillin / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D004340:Drug Contamination; D004355:Drug Stability; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D013055:Spectrophotometry, Infrared
D000900:Anti-Bacterial Agents; D002214:Capsules; D004364:Pharmaceutical Preparations; D004009:Dicloxacillin