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

Journal of Pharmaceutical and Biomedical Analysis

Volumn 70, Issue , 2012, Pages 592-597

  Venugopal, N ^a   Vijaya Bhaskar Reddy, A ^a   Gangadhar Reddy, K ^a   Madhavi, V ^a   Madhavi, G ^a  

^a SRI VENKATESWARA UNIVERSITY   (India)

Author keywords

ICH; LC MS MS; Pantoprazole sodium; Trace analysis; Validation

Indexed keywords

2 CHLOROMETHYL 3,4 DIMETHOXYPYRIDINE; ACETONITRILE; AMMONIUM ACETATE; PANTOPRAZOLE; PYRIDINE DERIVATIVE; UNCLASSIFIED DRUG;

ARTICLE; DRUG DETERMINATION; DRUG IMPURITY; FLOW RATE; GENOTOXICITY; LIQUID CHROMATOGRAPHY; PHARMACEUTICAL GENOTOXIC IMPURITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; TANDEM MASS SPECTROMETRY; VALIDATION STUDY;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ACETATES; ACETONITRILES; BUFFERS; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; LIMIT OF DETECTION; LINEAR MODELS; MUTAGENS; PROTON PUMP INHIBITORS; PYRIDINES; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; TANDEM MASS SPECTROMETRY;

EID: 84866264492     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.05.031     Document Type: Article

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