Comparative Pharmacokinetic Studies of Marketed and Microsponges Gel Loaded with Diclofenac Diethylamine in Rabbits

Abstract

Oral administration of the non-steroidal anti-inflammatory drug, Diclofenac Diethylamine (DDEA) is often associated with gastrointestinal ulcers, bleeding and extensive first-pass hepatic metabolism. As an alternative to oral administration, formulated microsponges-based gel of DDEA was developed for topical administration, to quantify diclofenac diethylamine in plasma of rabbits for this a sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed using carbamazepine as Internal standard (IS) and DDEA (pure drug) was provoked on Hypersil RP C18 column (250mm × 4.6mm 5µm) using a mobile phase mixture of potassium dihydrogen buffer pH 2.5 and acetonitrile in the ratio of 30:70 v/v at an isocratic flow rate of 1mL/min. The drug peak area was detection and found at 276nm. The retention time of DDEA was found to be 5.3 min. The calibration curve was linear over the concentration range of 50-750ng/ml of DDEA. This method was accurate for quantitative estimation of the drug from the marketed gel and optimized microsponge gel. The main of investigation is to compare pharmacokinetic profile of diclofenac diethylamine in pharmaceutical dosage forms (marketed gel and microsponges gel) using WinNonlin software version 8.1.