A simple and sophisticated RP-HPLC approach for quantifying of irinotecan in API and in pharmaceutical dosage form

Irinotecan is an anti-cancer drug used for the treatment of ovarian cancer. It works by inhibiting DNA-topoisomerase, type I. A simple, accurate and precise assay and rapid stability indicating RP-HPLC method has been developed and subsequently validated for the quantitative estimation of Irinotecan in API and its parental preparation. Proposed method is based on identification of drug Irinotecan in reversed phase mode using water’s C18 column maintained at an ambient temperature. The optimum mobile phase consist of mixture of Acetonitrile: Mixed phosphate buffer (potassium dihydrogen phosphate (0.01mm) with 1.0ml triethylamine) (30:70v/v) and pH was adjusted to 2.5 with O-Phosphoric acid (1:100,v/v). The flow rate was maintained at 0.8 ml/min. The injection volume was 20ml and detected at the wavelength of 221nm. The method was validated according to ICH guideline. The method was found to be accurate, reproducible and linear. The drug was exposed to variable stressed conditions and was analyzed by proposed method. There were no interfering peaks from exicipients, impurities or degradative products due to variable stress conditions. Thus the proposed method is specific for the quantitative estimation of Irinotecan and can be successfully applied in the quality control and stability sample of API and its parental preparation.