ABSTRACT:
This work aimed for the method development and validation of RP-HPLC method for quantitative determination of Irinotecan HCL in bulk and pharmaceutical formulation. More precise, accurate, sensitive, simple and economic HPLC method was developed and validated for quantitative determination of Irinotecan in bulk and dosage forms. Irinotecan was analyzed by using reverse phase Inertsil ODS 250 X 4.6 mm and 5µ particle size column. 0.02 M KH2PO4 buffer and acetonitrile were used as a mobile phase in the ratio of 40:60 v/v. The pH of the buffer was adjusted to 3.2 with o-phosphoric acid. The flow rate was 1.0 ml/min and the run time was 5 min. The analysis was carried out at 222 nm with UV detector at ambient temperature. The developed HPLC method was validated and stability studies were conducted under different conditions. Irinotecan was eluted at retention time 2.1 min and the calibration curve was linear in the range 40-120 µg/ml concentration. Correlation coefficient was found to be 0.9999. The Irinotecan test and standard stock solutions were stable over the period of 5 days. The LOD and LOQ were found to be 0.8 ng/ml and 2.0 ng/ml. % RSD of Irinotecan content was < 0.5% and the assay was found to be 98.2-100%. The proposed method is observed to be rapid and selective, when compared to the methods reported in the literature. The retention time of Irinotecan was found to be very less (2.1 min). The method is most precise and economic with respect to solvent consumption.