HPLC Assay Method Development and Validation for Quantification of Capecitabine in Tablets and Forced Degradation Samples

Abstract

A simple, rapid, accurate and stability indicating RP-HPLC

method was developed for the determination of Capecitabine

in pure and tablet dosage form. The mobile phase consisting

of 0.1% aqcetic acid, methanol and acetonitrile in the ratio of

35:60:5 v/v. The Inertsil ODS (octadecyl silane), C18, 3V, 250 x

4.6 mm, 5μm with UV detection 304 nm was used. The retention

time was found to be 6.4 minutes. The method was statistically

validated for accuracy, linearity, precision, robustness, specificity

and range. The method was found linear over the concentration

range of 50-150 μg/ml. The recovery studies of dosage form

were also carried out and analyzed; the % relative standard

deviation (RSD) from recovery studies was found to be within

limits. The specificity of the method was ascertained by forced

degradation studies by acid, alkali hydrolysis and oxidation.

About 35% of drug is degraded in acidic medium and less than

that in alkaline and oxidative conditions. Due to simplicity,

rapidity and accuracy of the method, the method will be useful

for routine analysis and checking purity of capecitabine tablet.

The method further can be investigated for pharmacokinetic

and biopharmaceutical analysis.

Keywords

• Capecitabine,5-fluorouracil,metastatic breast,colorectal cancer,RP-HPLC,ICH guidelines

References

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