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An improved RP-HPLC method for the quantitative determination of capecitabine in bulk and pharmaceutical tablet dosage form | Abstract
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Abstract

An improved RP-HPLC method for the quantitative determination of capecitabine in bulk and pharmaceutical tablet dosage form

Author(s): P. Ravisankar, G. Devala Rao, M. Naveen Kumar, M. Krishna Chaitanya

A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Capecitabine in tablet dosage forms. A Welchrom C18column having 250 × 4.6 mm i.d., 5 μm particle size in isocratic mode, with mobile phase containing Methanol:Acetonitrile:Water (50:30:20,v/v, pH adjusted to 4.6 using Triethylamine) was used. The flow rate was 1.0 ml/min and effluents are monitored at 245 nm. The retention time of Capecitabine is 4.123 min. The method was validated for specificity, linearity, accuracy, precision, limit of quantification, limit of detection, robustness in accordance with ICH guidelines. Limit of detection and limit of quantification for estimation of Capecitabine found to be 0.169247 μg/mL and 0.512872 μg/mL. Recovery of Capecitabine in tablet formulation was found to be 99.88 %. Proposed method was successfully applied for the quantitative determination of Capecitabine in commercially available tablet dosage forms.