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Validation of a RP-HPLC Method for the Quantitation of Vorinostat in Rat Plasma and its Application to a Pharmacokinetic Study

Ramesh Mullangi, Manish Gupta, Vinay Dhiman, Abhishek Dixit, Kalpesh Kumar Giri, Mohd Zainuddin, Ravi Kanth Bhamidipati, Purushottam Dewang, Sridharan Rajagopal and Sriram Rajagopal

A simple, specific and reproducible high-performance liquid chromatography (HPLC) assay method has been developed and validated for the estimation of vorinostat in rat plasma. The bioanalytical procedure involves extraction of vorinostat and phenacetin (internal standard, IS) from rat plasma with simple liquid-liquid extraction process. The chromatographic analysis was performed on a Waters Alliance system using a gradient mobile phase conditions at a flow rate of 1.0 mL/min and Symmetry Shield C18 column maintained at 35 ± 1°C. The eluate was monitored using an UV detector set at 245 nm. Vorinostat and IS eluted at 5.3 and 6.3 min, respectively and the total run time was 10 min. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. The calibration curve was linear over a concentration range of 255-5566 ng/mL (r2 = 0.995). The intra- and inter-day precisions were in the range of 2.60-7.93 and 3.99-8.64%, respectively. The validated HPLC method was successfully applied to a pharmacokinetic study in rats.