Abstract
A simple rapid stability-indicating isocratic assay has been developed and validated for the determination of paclitaxel in rabbit plasma. The forced degradation of paclitaxel in solution form under stress conditions including acid and base hydrolysis, oxidation and heat were also studied. The assay is performed using a mu Bondapak-C-18 (150 mm x 4.6 mm i.d) with a mobile phase consisted of acetonitrile and 20 mM phosphate buffer (pH 5) (50:50 % v/v), the flow rate was 1 mL min and UV detection at 229 nm. The method was found to be specific for paclitaxel in the presence of degradation products, no interfering peaks were observed with an overall analytical run time was 10 min. The percentage recovery were found to be 98.92-103.95 % and 94.4 -103.4 % for interday and intraday accuracy, respectively. Inter-day precision (reproducibility) was found to be 0.23-3.6 % RSD, while intraday precision (repeatability) was found to be 0.47-3.7 % RSD for the samples studied. The calibration curve was found to be linear with the equation y = 0.7576x + 0.1189, with a correlation coefficient of 0.9996 (R-2) over the concentration range 0.1-40 mu g/mL. The limit of quantitation was the lowest concentration. Degradation of paclitaxel in solution form was found to be more degradable to alkaline hydrolysis than other stress conditions. The study showed that the fully validated HPLC method is simple and rapid and can be used without requiring any preliminary treatment of the sample.