Peak Homogeneity Determination for the Validation of High-Performance Liquid Chromatographic Assay Methods

To validate high-performance liquid chromatographic assay procedures with regard to specificity, methods were developed to determine the homogeneity of the chromatographic peaks. These methods employed a rapid-scanning UV-visible spectrophotometer to monitor the chromatographic effluent. The absorption data were processed to nullify the signal due to the drug substance specifically, while allowing the detection of coincident impurities. Results from three model systems indicated the ability of these methods to detect as little as 0.1% of a coincident impurity.