A NEW ASSAY METHOD DEVELOPMENT AND VALIDATION OF TWO ANTI-CANCER DRUGS BY USING EFFECTIVE LIQUID CHROMATOGRAPHIC METHODAbstract
A simple, sensitive and rapid chromatographic method was developed and validated for quantification of Mitomycin and Fluorouracil in bulk and pharmaceutical dosage form using Symmetry C18 (4.6 × 150 mm, 3.5 µ) column. The mobile phase consists of buffer, 0.1% Ortho Phosphoric acid (OPA), and acetonitrile in the ratio of 50:50 v/v. The flow rate is maintained as at 1.0 ml/min; detection was carried out by absorption at 260 nm using photodiode array detector. The calibration curve was linear and the regression coefficient (R2) value was found to be 0.999 and concentrations ranging from 10-150 µg/ml of mitomycin and 5-75 µg/ml of fluorouracil, respectively. The LOD and LOQ of the method were found to be 0.1 µg/ml, 0.05 µg/ml and 1 µg/ml, 0.5 µg/ml for Mitomycin and Fluorouracil. The number of theoretical plates and tailing factors for Mitomycin and Fluorouracil were not less than 2000 and were not more than 2, respectively. The developed method was found to be simple, economical, suitable and validated according to ICH guidelines.
T. Jaison Jose *, Y. Subbareddy and K. Sankar
Department of Botany, Andhra Loyola College, Vijayawada, Andhra Pradesh, India.
15 October 2020
09 February 2021
09 October 2021
01 November 2021