US EPA

7459463 

Journal Article 

Bioanalytical method development and validation of capecitabine by RP-HPLC method 

Jayaseelan, S; Bajivali, SK; Ramesh, U; Sekar, V; Perumal, P 

2010 

0 

International Journal of ChemTech Research
ISSN: 0974-4290 

2 

4 

2086-2090 

English 

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 623.69- 8400.59 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%. 

5-bromouracil; Capecitabine; 5 bromouracil; acetonitrile; ammonium acetate; capecitabine; analytic method; article; chromatography; controlled study; drug determination; drug retention; drug stability; freeze thawing; high performance liquid chromatography; human; pH