Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Irrinotecan in Bulk and It’s Pharmaceutical Dosage Form

Bonagiri Pavani*¹, Dr. C. Hari kumar², Y. Kesava³, Dr.B.Mohammed Ishaq^4
1,2,3Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P, India
⁴Santhiram College of Pharmacy, Nandyala, A.P, India

ABSTRACT
A simple, sensitive, and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Irinotecan in bulk and tablet dosage forms. The HPLC separation was carried out by reverse phase chromatography on Waters (HPLC-2695) model with Inertsil ODS 250 X 4.6 mm and 5µ particle size column. The mobile phase was consist of  0.02 M KH₂PO₄ Buffer (pH was adjusted to  3.2 with Ortho phosphoric acid) and Acetonitrile mixed in the ratio of 40: 60 v/v. The mobile phase flow rate was set as 1 ml/min and total analysis was performed at wave length 222 nm with PDA Detector at ambient temperature. The developed HPLC method was validated and stability studies were conducted under different conditions.  Irinotecan compound was eluted at 2.1 min and the calibration curve was linear over the concentration range 40 – 120 µg/ml. Correlation coefficient was found to be 0.9999. % RSD of irinotecan content was found to be < 0.5%. Recovery was found to be 99.1%. The developed HPLC method was Robust and Rugged and successfully followed for the estimation of Irinotecan content present in injection dosage form as well in API.
Keywords: Irinotecan, Mobile phase, HPLC analysis, Method validation.