Validated, Reversed Phase High Performance Liquid Chromatography Method for The Estimation of Capecitabine in Pharmaceutical Formulations

K. Vanitha Prakash, J. Venkateswara Rao* and N. Appala Raju

Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Mount Pleasant, Road No. 3, Banjara Hills, Hyderabad - 500 034 India.

ABSTRACT:

Reversed phase high performance liquid chromatographic method was developed and validated for estimation of Capecitabine in tablet dosage form. A Phenomenex Prodgy C18, 150x4.6 mm i.d, 5 μm partical size, with mobile phase consisting of mixed buffer of 0.005 M potassium dihydrogen orthophosphate and 0.005 M dipotassium hydrogen orthophosphate (pH 6.8) and acetonitrile in the ratio of 70:30 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 240 nm. The retention time was 5.89 min. The detector response was linear in the concentration of 25-300 mcg/ml, with the regression coefficient of 0.9999. Quantification was done by calculating area of the peak and the detection and quantitation limits were 0.125 and 0.375 mcg/ml respectively. The percentage assay of Capecitabine was 99.91%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method can be applied for the determination of Capecitabine in quality control samples and formulations without interferences of the excipients present.

KEYWORDS:

Capecitabine; RP-HPLC; Estimation; Tablets

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Copy the following to cite this article: Prakash K. V, Rao J. V, Raju N. A. Validated, Reversed Phase High Performance Liquid Chromatography Method for The Estimation of Capecitabine in Pharmaceutical Formulations. Orient J Chem 2008;24(1).

Copy the following to cite this URL: Prakash K. V, Rao J. V, Raju N. A. Validated, Reversed Phase High Performance Liquid Chromatography Method for The Estimation of Capecitabine in Pharmaceutical Formulations. Orient J Chem 2008;24(1). Available from: http://www.orientjchem.org/?p=23331