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1 2009

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

Shende P., Gaud R.

Acta Chromatographica

2009

Vol. 21, no. 1

71-82

An isocratic reversed-phase high-performance liquid chromatographic (RPHPLC) 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 µg 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.