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

Authors: Srilatha M , Naresh K , Sruthi G , Praneeth G and Madhusudan Rao Y

DOI: 10.23880/pdraj-16000133

Volume 5, Issue 1

Abstract

Oral administration of the non-steroidal anti-inflammatory drug, Diclofenac diethylamine (DDEA) is often associated with gastrointestinal ulcers, extensive first-pass hepatic metabolism, and gastric bleeding. As an alternative to oral administration, a transdermal drug delivery system (TDDS) 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 to compare DDEA in marketed gel and optimized formulation, using Carbamazepine as Internal standard (IS). DDEA provoke on Hypersil RP C18 column (250 mm × 4.6 mm 5 μm) using a mobile phase mixture of potassium dihydrogen buffer pH 2.5 and acetonitrile in the ratio of 30:70v/v at an isocratic flow rate of 1mL/min. The retention time of DDEA was found to be 5.3min. The calibration curve was linear over the concentration range from 50-750ng/mL of DDEA. This method was accurate for quantitative estimation of the drug in marketed gel and optimized formulation. The main aim of study is to compare Pharmacokinetic profile of diclofenac diethylamine in pharmaceutical dosage forms (Marketed gel & formulated transdermal patches) using WinNonlin software version 8.1.

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