Bioanalytical Method Development and Validation of Capecitabine by RP-HPLC Method

A rapid high-performance liquid chromatographic bioanalytical method has been developed and validated for capecitabine in human plasma. Capecitabine a prodrug of 5-fluorouracil (5-FU), is an oral tumor – selective fluoro pyrimidine carbamate approved in the treatment of colorectal and breast cancer. Capecitabine was found with symmetrical peak shapes on an analytical column, Phenomenex Luna C18 using 70% Ammonium acetate with pH 5.0 and 30% acetonitrile as the mobile phase. The retention times of capecitabine and 5-bromouracil the internal standard were 5.7 and 7.8 min respectively. Linear calibration curves were obtained for each compound across a range of 623.698400.59 ng/ml. The limit of detection and limit of Quantification were found to be 300ng/ml and 600ng/ml respectively for capecitabine. Greater than 90% recoveries were obtained for capecitabine. The intra and interday relative standard deviation (%RSD) were found to be <5%.