A thin-layer chromatographic method to determine process impurities in leucovorin calcium.
A densitometric thin-layer chromatographic method for the analysis of process impurities in leucovorin calcium was developed and validated. Using this method, folic acid, N10-formyldihydrofolic acid, p-aminobenzoic acid, and N-(4-aminobenzoyl)-L-glutamic acid were monitored with a limit of detection of approximately 0.1% each. Both absorbance and fluorescence densitometric evaluations were utilized; fluorescence evaluation selectively detected impurities that were not chromatographically resolved from leucovorin.
White
D
D
Burroughs Wellcome Company, Analytical Development Laboratories, Greenville, NC 27835.
Varlashkin
P
P
Rusch
D N
DN
D010129:4-Aminobenzoic Acid / Q000032:analysis; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002855:Chromatography, Thin Layer / Q000379:methods; D003720:Densitometry / Q000379:methods; D005492:Folic Acid / Q000031:analogs & derivatives / Q000032:analysis; D005971:Glutamates / Q000032:analysis; D002955:Leucovorin / Q000032:analysis* / Q000302:isolation & purification; D008027:Light; D015203:Reproducibility of Results
D005971:Glutamates; C012324:10-formylfolic acid; D005492:Folic Acid; C011398:4-aminobenzoylglutamic acid; D002955:Leucovorin; D010129:4-Aminobenzoic Acid