BIO ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CAPECITABINE AND DOCETAXEL AND ITS APPLICATION TO PHARMACOKINETIC STUDIES USING LC-MS/MS

Abstract

Objective: An easy, quick, precise, active and reproducible Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) technique was developed for the bio-analytical method of Capecitabine and Docetaxel using D9-Capecitabine and D9-Docetaxel as Internal Standards (IS). Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using Symmetry C18 column (150x4.6 mm, 3.5µ) and an organic mobile phase of 0.1% formic acid and Acetonitrile in 80:20 v/v. Results: Analysis was carried out within 5 min over a good linear concentration range from 37.5ng/ml to 300ng/ml (r2= 0.9999±0.008) for Capecitabine and 10ng/ml to 80ng/ml (r2=0.9993±0.005) for Docetaxel. Accuracy, precision, recovery, matrix effect and stability results were found to be within suitable limits. Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with United States Food and Drug Administration (USFDA) guidelines and applied effectively for the investigation of pharmacokinetic studies in rats.