The Estimation of Irinotecan HCl in Parenterals by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Irinotecan HCl in tablet dosage form. A X-Terra RP C18, 250x4.6 mm i.d, 5 μm partical size, with mobile phase consisting of Methanol and 0.01 M Ammonium Acetate containing 0.1% formic acid and methanol in the ratio of 50:50 v/v was used. The flow rate was 1 ml/min and the effluents were monitored at 250 nm. The retention time was 4.69 min. The detector response was linear in the concentration of 120–360 mcg/ml. The respective linear regression equation being Y=166582.24x+86439.5. The limit of detection and limit of quantification was 0.06 and 0.18 mcg/ml respectively. The percentage assay of Irinotecan HCl was 99.09%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Irinotecan HCl in bulk drug and in its pharmaceutical dosage form.