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E-Journal of Chemistry
Volume 4, Issue 1, Pages 128-136
http://dx.doi.org/10.1155/2007/597409

Validated Reverse Phase HPLC Method for the Determination of Irinotecan in Pharmaceutical Dosage Forms

Murali Balaram V.,1 VENKATESWARA Rao J.,1 Ramakrishnag S. Sankar Ganesh G.,2 and Balamurali Krishna T.3

1Department of Pharmaceutical Analysis, Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant Road No.3, Banjara Hills, Hyderabad-34, India
2Pharmacology Division, Indian Institute of Chemical Technology, Hyderabad-7, India
3BGSS Pharma, 512, Meridian Plaza, Hyderabad-34, India

Received 30 August 2006; Accepted 15 October 2006

Copyright © 2007 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A simple and rapid reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for quantitative determination of irinotecan in bulk drug samples and formulations. Irinotecan was analyzed by using reverse phase cyano column (4.6 mmx25 cm, 5 microns), with mobile phase consisting of phosphate buffer: acetonitrile (75:25 v/v), pH adjusted to 2.5 with phosphoric acid. The flow rate was set 0.8 mL/min and the analysis was performed at wavelength 225 nm using Photo Diode Array (PDA) detector at ambient temperature. The method was validated and stability studies were conducted under different conditions. The retention time for irinotecan was around 5.82 minutes. The calibration curves were linear (r ≥ 0.9998) over a concentration range from 20.0 to 80.0 μg/mL. Limit of detection (LOD) and Limit of quantitation (LOQ) were 8 ng/mL and 24 ng/mL respectively. The developed method was successfully applied to estimate the amount of irinotecan in injection formulations.