Abstract

TO DEVELOP A SIMPLE, PRECISE, AND ACCURATE RP-HPLC METHOD FOR ESTIMATION OF CAPECITABINE IN BULK DRUG AND DOSAGE FORM AND TO VALIDATE THE DEVELOPED METHOD AS PER ICH Q2R1 GUIDELINES

Poonam Vijay Walekar*, Pooja Bhagwat Tarakh, V. G. Rajurkar and Pravin
Atmaram Rathod

ABSTRACT

A new, rapid and commercial isocratic reversed-phase highperformanceliquid chromatography (RP-HPLC) method was developedfor the determination of capecitabine, a small synthetic antiplateletpeptide, in pharmaceutical and prescription drugs. The manufacturingprocess was validated according to ICH guidelines. The mobilephases were acetonitrile (ACN), water and trifluoroacetic acid (TFA)eluted at a flow rate of 1 mL/min and UV isocratic chromatographywas performed on a C18 column (150 x 4.60 mm id, 5 μM particlesize) at ambient temperature and detected at 275 nm. Eptifibatide acetateis linear in the concentration range of 0.15-2 mg/mL (r2=0.997)and the detection limit is 0.15 mg/mL. Inter-day and intraday exposureis 0.052% and 0.598%, respectively. This model is well defined andhas good selectivity, linearity, sensitivity, precision and accuracy, and is suitable for the determinationof eptifibatide acetate in raw materials and medicinal products. Keywords: capecitabine,HPLC-UV, determination, API, formulation. A simple, rapid, accurate and costeffectiveUV method was investigated for the estimation of capecitabine content in variousmedicinal products. This new method was developed using Shimadzu Spectronic Model 1800UV-Vis spectrophotometer. It was found that the region between 295nm and 305nm of theUV spectrum with distilled water as solvent was suitable for the measurement of capecitabine,the line was more than the concentration of 40μg/ml to 80μg/ml. This method has been successfully used in routine analysis of drug tablets. The procedure was validated accordingto ICH guidelines. No effect of the supplement was observed.

Keywords: Capecitabine, UV-visible spectroscopic method, HPLC method, Validation, ICH Guidelines.