The application of sub-2-μm particle liquid chromatography-operated high mobile linear velocities coupled to orthogonal accelerated time-of-flight mass spectrometry for the analysis of ranitidine and its impurities

Journal of Separation Science

Volumn 29, Issue 16, 2006, Pages 2409-2420

  Jones, Michael D ^a   Plumb, Robert S ^a  

^a WATERS CORPORATION   (United States)

Author keywords

Impurity profiling; Mass spectrometry; Orthogonal acceleration time of flight; Ranitidine; Ultra performance liquid chromatography

Indexed keywords

COMPUTER SIMULATION; DRUG PRODUCTS; HYDROCHLORIC ACID; MASS SPECTROMETRY; PH;

IMPURITY PROFILING; ORTHOGONAL ACCELERATION TIME OF FLIGHT; RANITIDINE; TIME-OF-FLIGHT MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

LIQUID CHROMATOGRAPHY;

DIMER; DRUG METABOLITE; METHAMPHETAMINE; METHANOL DERIVATIVE; OXIDE; OXIME; RANITIDINE; HISTAMINE H2 RECEPTOR ANTAGONIST;

ARTICLE; COMPUTER PROGRAM; DRUG FORMULATION; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG STRUCTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PARTICLE SIZE; PH; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SENSITIVITY AND SPECIFICITY; STRUCTURE ANALYSIS; TIME OF FLIGHT MASS SPECTROMETRY; CHEMICAL MODEL; CHEMISTRY; ISOLATION AND PURIFICATION; LIQUID CHROMATOGRAPHY; METHODOLOGY; TIME;

CHEMISTRY, ANALYTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, LIQUID; HISTAMINE H2 ANTAGONISTS; MASS SPECTROMETRY; MODELS, CHEMICAL; RANITIDINE; TIME FACTORS;

EID: 33751285938     PISSN: 16159306     EISSN: 16159314     Source Type: Journal    
DOI: 10.1002/jssc.200600118     Document Type: Article

References (10)

1. International Conferences on Harmonization, Draft Revised Guidance on Impurities in New Drug Substances. Q3A(R). Federal Register 2000, 65(140), 45085-45090.
2. International Conferences on Harmonization, Draft Revised Guidance on Impurities in New Drug Products. Q3B(R). Federal Register 2000, 65(139), 44791-44797.
3. International Conferences on Harmonization, Impurities - Guidelines for Residual Solvents. Q3C. Federal Register 1997, 62(247), 67377.
4. Evans, M. B., Haywood, P. A., Johnson, D., Martin-Smith, M. et al., J. Pharm. Biomed. Anal. 1989, 7, 1-22.
5. United States Pharmacopeia XXIV, United States Pharmacopeial Convention, Rockville 2000, p. 1463.
6. Kelly, M. A., Altria, K. D., Grace, C., Clark, B. J., J. Chromatogr. A 1998, 798, 297-306.
7. Mellors, J. S., Jorgenson, J. W., Anal. Chem. 2004, 76, 5441-5450.
8. Wilson, I. D., Nicholson, J. K., Castro-Perez, J., Granger, J. H. et al., J. Proteome Res. 2005, 4, 591-598.
9. Castro-Perez, J., Plumb, R. S., Granger, J. H., Beatie, I. et al., Rapid Commun. Mass Spectrom. 2005, 19, 843-848.
10. Plumb, R. S., Granger, J. H., Stumpf, C. L., Johnson, K. A. et al., Analyst 2005, 130, 844-849.