Title:A Validated Stability-Indicating HPTLC Method for the Estimation of Capecitabine in its Tablet Dosage Form
VOLUME: 15 ISSUE: 1
Author(s):Sonali Thorat*, Rupesh Chikhale, Vanita Rode and Madhukar Tajne
Affiliation:Department of Pharmaceutical Sciences, Rasthrasant Tukadoji Maharaj Nagpur University, Nagpur - 440 033 (MS), Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Mumbai- 410 210 (MS), Department of Pharmaceutical Sciences, Rasthrasant Tukadoji Maharaj Nagpur University, Nagpur - 440 033 (MS), Department of Pharmaceutical Sciences, Rasthrasant Tukadoji Maharaj Nagpur University, Nagpur - 440 033 (MS)
Keywords:Capecitabine, prodrug, high-performance thin-layer chromatography, stability-indicating stress degradation, tablet
dosage, anticancer drug.
Abstract:Background: Capecitabine is an orally available prodrug of 5-flurouracil used in the treatment
of breast cancer, metastatic colorectal cancer and stage III colorectal cancer. Various studies have
reported the HPLC, HPLC-MS, MS/MS methods for estimation of capecitabine. However, till date
HPTLC method for estimation of capecitabine and its validation is not reported in tablet dosage form.
Introduction: Presented study deals with the development and validation of stability indicating high
performance thin layer chromatography method for the determination of Capecitabine in tablet dosage
form.
Methods: The method was developed using precoated HPTLC plates with silica gel 60 F254 as stationary
phase and toluene-methanol the ratio of 7.5:2.5 v/v as the mobile phase. Capecitabine (RF 0.48 ±
0.03) and its degradation products were well resolved. The wavelength selected for study was 240 nm.
The method was linear in the concentration range 50–550 ng/band with a correlation coefficient of
0.994. The repeatability for six samples was 1.25% RSD. The intraday and interday precisions were
1.46-1.71%RSD and 1.31-1.67% RSD, respectively. The accuracy (recovery) was found to be in the
range of 99.10-101.23% with LOD and LOQ were found to be 0.650 and 1.765 mg/band. The mean
content of drug in tablet dosage form was found to be 101.51% with a % RSD of 1.20. The drug was
subjected to stress conditions such as hydrolysis, oxidation, photolysis, and heat.
Results: Degradation products produced as a result of the stress conditions did not interfere with the
detection of Capecitabine; therefore, the proposed technique can be considered stability-indicating.
Capecitabine did not degrade under thermal and photolytic conditions but showed degradation under
acidic and alkaline conditions with 15 and 11% decompositions respectively.
Conclusion: The developed method was found to be facile, simple, specific, precise, and stabilityindicating.
It can be employed for the routine analysis of capecitabine in tablet dosage form.
