11. An improved HPLC-UV method for the estimation of Irinotecan in bulk and tablet dosage form

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Irinotecan in tablet dosage form. An Inertsil ODS C-18, 5μm column having 250 x 4.6mm internal diameter in isocratic mode with mobile phase containing acetonitrile: methanol: 0.01M KH2PO4 in the ratio of 55:18:27 (v/v/v) was used. The flow rate was 1.5 mL/min and effluents were monitored at 220 nm. The retention time for Irinotecan was 2.9 min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found to be 10ng/mL and 35ng/mL, respectively. The proposed method was successfully applied for the quantitative determination of Irinotecan in Irnocam 100mg tablets. The recovery of Irinotecan from tablet formulation was found to be 101.82%. The high recovery and less run time confirm the suitability of the proposed method for the routine quality control analysis of Irinotecan in bulk and tablet dosage form.