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1.
J Pharm Biomed Anal ; 49(1): 156-62, 2009 Jan 15.
Article in English | MEDLINE | ID: mdl-19056198

ABSTRACT

Three process-related impurities were observed in routine monitoring of the samples by HPLC. These impurities were identified by LC-MS. One of the impurities, Imp-3 [rizatriptan-2,5-dimer] was reported in literature. Other two impurities were isolated by preparative HPLC and characterized by NMR, Mass and IR. Pure impurities obtained by isolation were co-injected with Rizatriptan benzoate sample to confirm the retention times in HPLC. Structure elucidation of these impurities by spectral data has been discussed in detail. These impurities were identified as 4-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)ethyl)-1H-indol-1-yl)-4-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)ethyl)-1H-indol-2-yl)-N,N-dimethylbutan-1-amine [rizatriptan-1,2-dimer] and [4,4-bis-(5-((1H-1,2,4-triazol-1-yl)methyl)-3-(2-(dimethylamino)-ethyl)-1H-indol-2-yl)-N,N-dimethylbutan-1-amine [rizatriptan-2,2-dimer].


Subject(s)
Drug Contamination , Serotonin Receptor Agonists/chemistry , Triazoles/chemistry , Tryptamines/chemistry , Chromatography, High Pressure Liquid/methods , Magnetic Resonance Spectroscopy/methods , Mass Spectrometry/methods , Molecular Structure , Reproducibility of Results , Serotonin Receptor Agonists/analysis , Serotonin Receptor Agonists/standards , Spectrophotometry, Infrared/methods , Triazoles/analysis , Triazoles/standards , Tryptamines/analysis , Tryptamines/standards
2.
J Pharm Biomed Anal ; 43(4): 1470-5, 2007 Mar 12.
Article in English | MEDLINE | ID: mdl-17125952

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents/analysis , Dicloxacillin/analysis , Pharmaceutical Preparations/analysis , Anti-Bacterial Agents/chemistry , Anti-Bacterial Agents/standards , Capsules , Chromatography, Liquid , Dicloxacillin/chemistry , Dicloxacillin/standards , Drug Contamination , Drug Stability , Magnetic Resonance Spectroscopy , Mass Spectrometry , Molecular Structure , Pharmaceutical Preparations/chemistry , Pharmaceutical Preparations/standards , Spectrophotometry, Infrared
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