Validated RP-HPLC Analysis of Irinotecan HCl in the Bulk Material and in Pharmaceutical Formulations

摘要

An isocratic reversed-phase high-performance liquid chromatographic (RP-HPLC) method for analysis of irinotecan HCl has been developed and validated. Separation was achieved on a C-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(-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(-1) for assay of irinotecan HCl. 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.