Abstract

RP-HPLC METHODE DEVELOPMENT AND VALIDATION FOR ESTIMATION OF “CAPECITABINE” AS API & DOSAGE FORM

Priya Vishwanath Mijgar*, Shilpa Pandharinath Dakhurkar, Snehal Dilip Wani, Prachi Madhukar Murkute

Abstract

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 C18column having 250 × 4.6 mm and mobile phase containing Methanol: Water (50:50v/v) was used. The flow rate was 1.0 ml/min and effluents are monitored at 241 nm. The retention time of Capecitabine is 3.15 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 2.13 μg/ml and 6.46 μg/ml. Recovery of Capecitabine in tablet formulation was found to be 98.64%. Proposed method was successfully applied for the quantitative determination of Capecitabine in commercially available tablet dosage forms.

Keywords: Capecitabine, RP-HPLC Method development, Validation.