Alternatives to amino acid analysis for the purity control of pharmaceutical grade L-alanine.
The quality control of drugs is important for safety of patients and consumers. International pharmacopoeias mostly employed HPLC with UV detection for this purpose. This is always a problem when the drugs, such as most amino acids, are lacking a chromophor. Instead of UV detection, the impurity control of alanine was performed using charged aerosol detector, evaporative light-scattering detector, nano quantity analyte detector, MS detector, and as an orthogonal method, quantitative NMR spectroscopy. The charged aerosol detector, MS detector, and quantitative NMR spectroscopy provided similar and precise results, whereas the evaporative light-scattering detector and nano quantity analyte detector revealed some problems regarding sensitivity, linearity, and robustness.
Holzgrabe
Ulrike
U
University of Wuerzburg, Institute of Pharmacy and Food Chemistry, Wuerzburg, Germany. u.holzgrabe@pharmazie.uni-wuerzburg.de
Nap
Cees-Jan
CJ
Beyer
Tanja
T
Almeling
Stefan
S
D000336:Aerosols / Q000032:analysis; D000409:Alanine / Q000032:analysis* / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination / Q000517:prevention & control; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D036103:Nanotechnology; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods*
D000336:Aerosols; D004364:Pharmaceutical Preparations; D000409:Alanine