Journal of Pharmaceutical Sciences 1992-12-01

A thin-layer chromatographic method to determine process impurities in leucovorin calcium.

D White, P Varlashkin, D N Rusch

Index: J. Pharm. Sci. 81(12) , 1204-9, (1992)

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Abstract

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.