Method development and validation study for quantitative determination of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride a genotoxic impurity in pantoprazole active pharmaceutical ingredient (API) by LC/MS/MS.
J Pharm Biomed Anal
; 70: 592-7, 2012 Nov.
Article
en En
| MEDLINE
| ID: mdl-22749172
ABSTRACT
A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC/MS/MS) method was developed and validated for the trace analysis (>1 ppm level) of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride a genotoxic impurity in pantoprazole sodium drug substances. LC/MS/MS analysis of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride was done on Hypersil BDS C18 (50 mm × 4.6 mm) 3 µm column and 10 mM ammonium acetate in 1000 mL of water was used as buffer. The mobile phase used was in the ratio of buffer-acetonitrile (7921, v/v). The flow rate was 1.0 mL/min and elution was monitored at 210 nm. The method was validated as per International Conference on Harmonization (ICH) guidelines. LC/MS/MS is able to quantitate up to 0.3 ppm of 2-chloromethyl-3,4-dimethoxy pyridine hydrochloride.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Contaminación de Medicamentos
/
Cromatografía Líquida de Alta Presión
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2-Piridinilmetilsulfinilbencimidazoles
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Espectrometría de Masas en Tándem
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Inhibidores de la Bomba de Protones
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Mutágenos
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2012
Tipo del documento:
Article
País de afiliación:
India