Development and validation of a rapid liquid chromatographic method for the analysis of Ketorolac Tromethamine and its related production impurities.

ABSTRACT

A high performance liquid chromatographic (HPLC) method for the analysis of ketorolac tromethamine and its associated impurities was examined with the aim of reducing analysis times while maintaining good efficiency. The separation was carried out using a waters X-bridge – C8 (3mm x75mm, 2.5μm particle size) column with a mobile phase of tetrahydrofuran – ammonium dihydrogen phosphate (0.05M, pH3, 2872 v/v) at a flow rate of 1.7mL/min and UV detection at 313nm. The method was validated according to ICH (international conference on harmonisation) guidelines with respect to precision, accuracy, linearity, specificity, robustness and limits of detection and quantification. All parameters examined were found to be well within the stated guidelines. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was presented. A three-fold reduction in analysis time was achieved in comparison with the current approved EP (european pharmacopeia) method and the method can be immediately used for routine assay and related substance determination.