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

Area of Science:

• Pharmaceutical Analysis
• Chromatography
• Drug Quality Control

Background:

• Leucovorin calcium is a critical medication, and its purity is essential for patient safety.
• Process impurities can affect the efficacy and safety of pharmaceutical products.
• Accurate analytical methods are required for monitoring these impurities.

Purpose of the Study:

• To develop and validate a densitometric thin-layer chromatographic (TLC) method for analyzing process impurities in leucovorin calcium.
• To establish a sensitive and selective method for impurity profiling.
• To ensure the quality and safety of leucovorin calcium formulations.

Main Methods:

• Development and validation of a densitometric thin-layer chromatographic method.
• Utilizing both absorbance and fluorescence densitometric evaluations.
• Monitoring specific impurities including folic acid, N10-formyldihydrofolic acid, p-aminobenzoic acid, and N-(4-aminobenzoyl)-L-glutamic acid.

Main Results:

• The developed TLC method achieved a limit of detection of approximately 0.1% for key impurities.
• Fluorescence densitometry demonstrated superior selectivity, detecting impurities not resolved by chromatography alone.
• The method was validated for the analysis of process impurities in leucovorin calcium.

Conclusions:

• A validated densitometric TLC method provides accurate analysis of leucovorin calcium impurities.
• Fluorescence detection enhances impurity profiling by identifying co-eluting compounds.
• This method is crucial for ensuring the quality control and safety of leucovorin calcium products.