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, 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.
McCrossen
S D
SD
SmithKline Beecham Pharmaceuticals, Tonbridge, Kent, UK. SeanMcCrossen-1@sbphrd.com.uk@inet
Bryant
D K
DK
Cook
B R
BR
Richards
J J
JJ
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D008027:Light; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D012031:Refractometry / Q000379:methods; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet / Q000379:methods