Validated RP-HPLC analysis of irinotecan HCI in the bulk material and in pharmaceutical formulations

An isocratic reversed-phase high-performance liquid chromatographic (RPHPLC) method for analysis of irinotecan HCI has been developed and validated. Separation was achieved on a C sub(18) column with potassium dihydrogen phosphate buffer (pH adjusted to 3.5 with orthophosphoric acid)-acetonitrile-methanol 55:25:20 (v/v) as mobile phase at a flow rate of 1.0 mL min super(-1). UV detection was performed at 254 nm. The method is simple, sensitive, rapid, and selective, and linear over the range 30-70 mu g mL super(-1) for assay of irinotecan HCI. The precision of the assay method was below 1.0% RSD. Mean recovery was in the range 98.0-102.0%. Recovery of the active pharmaceutical ingredient from dosage forms ranged from 99.0 to 101.0. The method is useful for quality control in bulk manufacture and of the pharmaceutical formulation.