Method development, degradation pathway and kinetic of capecitabine
Journal Title: International Journal of Pharmaceutical Chemistry and Analysis - Year 2018, Vol 5, Issue 3
Abstract
The present work describes a simple accurate and precise Stability indicating RPHPLC method for the estimation of Capecitabine CPT in bulk and pharmaceutical formulation The Mobile phase used was Acetonitrile Water 60 40vv with 1mlmin flow rate and 240nm was used as a wavelength maximum The C18 HS 250 X 46 mm 5 m column was used as a stationary phase The method was validated as per the ICHQ2 Guidelines The retention time of CPT was found to be 33 min A linear response was observed in the range of 1050 gmL with a regression coefficient of 0999 The LOD and LOQ were found to be 143gmL and 434gmL respectively This method can be used for the determination of CPT in quality control of API and dosage form without interference of the excipients impurities and degradation products and hence can be used as stability indicating assay method CPT was subjected to degradation under different stress conditions recommended by ICH viz acid alkali photolytic dry heat and oxidative condition The samples so generated were used for degradation studies including degradation kinetic study using the developed method The degradation pathway of CPT was found to be acid hydrolysis and temperature exceeding 100c The degradation kinetic study shows that the acid hydrolysis alkaline hydrolysis and oxidative degradation of the CPT follow first order kinetic Keywords Anticancer drug Capecitabine Degradation Stability indicating assay method Validation
Authors and Affiliations
Dhara R. Patel
Keywords
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- EP ID EP481451
- DOI 10.18231/2394-2797.2018.0021
- Views 90
- Downloads 0
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