alexa Abstract | Development of validated RP-HPLC-PDA method for the analysis of Capecitabine in bulk, dosage forms and in dissolution samples

Journal of Chemical and Pharmaceutical Research
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Abstract

The present study was aimed at developing a simple, specific, efficient and sensitive RP-HPLC-PDA method for the estimation of capecitabine in bulk, dosage forms and in vitro in dissolution samples. Separation was carried out on Phenomenex C18 reverse phase column (250× 4.6mm, 5 μm) employing a mobile phase consisting of 15mM Ammonium acetate: methanol (35:65 v/v) at flow rate of 1mL/min and UV detection at 240nm. The retention time of capecitabine was 6.7 min. The linearity was achieved over a concentration range of 2-10μg/mL (R2 =0.999), the limit of detection and limit of quantification were 0.065μg/mL and 0.195μg/mL respectively. The method was validated for parameters like accuracy, precision, assay, linearity, specificity, stability and robustness. Validation acceptance criteria were met in all the cases. The proposed method can be used for the determination of capecitabine and monitoring its concentration in in vitro dissolution studies.

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Author(s): A Karthik K Vasantha G Lakshmi Suneetha M Sai Sree and Buchi N Nalluri

Keywords

Capecitabine, dissolution, method validation, RP-HPLC., Capecitabine

 
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