Development and Validation of UFLC Method for the Determination of Docetaxel in Rat Plasma and Its Application in Pharmacokinetic Interaction with Diclofenac Sodium

Srikanth ReddyThummalapelly¹, Mounika Arrabelli², Raghuram Reddy Adidala*^1
1Sri Shivani College of Pharmacy, Mulugu road, Warangal, A.P, India.
²Synapse Life Sciences, Nakkalagutta, Hanamkonda, Warangal, A.P, India.

Abstract
In cancer, the taxane of choice has historically been paclitaxel however, there is no substantial evidence that docetaxel  may be the preferred taxane in this disease. Docetaxel has many preclinical advantages over paclitaxel and has been effective in both platinum and paclitaxel resistant disease. Even though, Docetaxel is the drug of choice for the treatment of cancer, its use is limited due to the limited or low bioavailability (8%). Hence, the present study is designed to develop a method on UFLC and validation of the developed method for the detection of Docetaxel in rat plasma. Chromatography was performed with an analytical Kromasil C18 column (250 x 4.6mm, 5μm), UFLC Chromatograph (Shimadzu SPD-M20A Photo Diode Array Detector and   UFLC-20AD Pump (Japan), using acetonitrile and 20mmol Phosphate buffer pH-5 (57:43% v/v) as the mobile phase. The average extraction recovery of Docetaxel from rat plasma was greater than 92% with a good linearity of 0.997 in plasma over a concentration range of 60,600 and 6000ng/ml. Interday and intraday variability was < 10% in plasma. This newly developed UFLC method was applied to the pharmacokinetic study of Docetaxel in the presence of Diclofenac sodium after oral administration in rats.
Keywords: Docetaxel, Diclofenac sodium, Pharmacokinetics, UFLC