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A Validated Stability-Indicating HPTLC Method for the Estimation of Capecitabine in its Tablet Dosage Form

[ Vol. 15 , Issue. 1 ]

Author(s):

Sonali Thorat*, Vanita Rode, Madhukar Tajne and Rupesh Chikhale   Pages 61 - 66 ( 6 )

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.

Method: 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.

Keywords:

Capecitabine, prodrug, high-performance thin-layer chromatography, stability-indicating stress degradation.

Affiliation:

University Department of Pharmaceutical Sciences Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur – 440 033 (MS), University Department of Pharmaceutical Sciences Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur – 440 033 (MS), University Department of Pharmaceutical Sciences Rashtrasant 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) c



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