TY - JOUR
T1 - Development and validation of a rapid liquid chromatographic method for the analysis of ketorolac tromethamine and its related production impurities
AU - O'Connor, N.
AU - Geary, M.
AU - Wharton, M.
AU - Curtin, L.
PY - 2012/5
Y1 - 2012/5
N2 - 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, 28:72 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.
AB - 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, 28:72 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.
KW - Active pharmaceutical ingredient
KW - Ketorolac tromethamine
KW - Method development
KW - Sub 2 μm column
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=84876040570&partnerID=8YFLogxK
U2 - 10.7324/JAPS.2012.2524
DO - 10.7324/JAPS.2012.2524
M3 - Article
AN - SCOPUS:84876040570
SN - 2231-3354
VL - 2
SP - 15
EP - 21
JO - Journal of Applied Pharmaceutical Science
JF - Journal of Applied Pharmaceutical Science
IS - 5
ER -