Open AccessNewly Developed Highly Sensitive Method for the Determination of Capecitabine by Using UV-Spectroscopy
Author(s) -
Manas Ranjan Mishra,
Punam Agrawal,
Surya Narayan Das
Publication year - 2019
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2019.110304
Subject(s) - capecitabine , linearity , dosage form , chromatography , correlation coefficient , solvent , methanol , robustness (evolution) , chemistry , biomedical engineering , colorectal cancer , mathematics , medicine , cancer , statistics , electronic engineering , engineering , organic chemistry , biochemistry , gene
Capecitabine is a 'pro-drug' to the cytotoxic agent 5-fluorouracil (5-FU) intended to administered orally. Capecitabine is generally used as first line monotherapy for advanced colon cancer. Simple, rapid, accurate UV spectrophotometric methods were developed in the present study and validated for the estimation of Capecitabine in bulk and its formulations as per ICH guidelines. Three solvent systems viz., 0.1N NaOH, 0.1N HCl and Methanol: Water (1:3) was tried. The results suggest that the developed method shows linearity over the range of concentration 2-24μg/ml and a correlation coefficient of 0.9999. Accuracy, precision, linearity, robustness, and ruggedness were statistically validated as per ICH guidelines for all the developed methods. The % RSD values for validated methods were found to be less than 1.5 and methods will find application in routine analysis of drug formulations containing Capecitabine.