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.
402 Absract views 15 PDF Downloads 417 Total views
A comparative study of physical parameters of selected ketorolac tromethamine tablets available in the pharma market of BangladeshNishat Nasrin, Muhammad Asaduzzaman, Rumana Mowla, Farhana Rizwan, Ashiqul Alam
UPLC method development and validation for Cefditoren Pivoxil in active pharmaceutical IngredientRam Garg, Navneet Singh, Kona S. Srinivas, Binayak Deb, Ayaz Ahmed
Development and validation of dissolution proceduresBhavesh Vaghela, Rajan Kayastha, Nayana Bhatt, Nimish Pathak, Dashrath Rathod