Comparison of LC detection methods in the investigation of non-UV detectable organic impurities in a drug substance

HPLC Analysis with different detection methods was shown to be essential in the separation and identification of unknown organic impurities in a drug substance. The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, r...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1998-07, Vol.17 (3), p.455-471
Main Authors: McCrossen, S.D., Bryant, D.K., Cook, B.R., Richards, J.J.
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Chromatography, High Pressure Liquid - methods
Chromatography, Liquid - methods
Detection
Drug Contamination
Drug substance
Evaporative light scattering
General pharmacology
Impurities
Indirect detection
LC-MS
LC-NMR
Light
Magnetic Resonance Spectroscopy - methods
Medical sciences
Pharmacology. Drug treatments
Refractive index
Refractometry - methods
Sensitivity and Specificity
Spectrophotometry, Ultraviolet - methods
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Summary:HPLC Analysis with different detection methods was shown to be essential in the separation and identification of unknown organic impurities in a drug substance. The impurities were found to exhibit very weak or no response to standard ultraviolet (UV) absorption detection. LC-MS, LC-NMR, indirect, refractive index and evaporative light-scattering detection were used to quantify and identify the impurities in this specific case. The drug substance studied was found to be an ideal analyte for demonstrating the advantages and limitations of several chromatographic detection systems for impurity profile analysis.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(97)00235-5