1Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi – 110062, India
2Department of Pharmacognosy & Phytochemistry, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi – 110062, India
*Corresponding Author E-mail: javedaali@yahoo.com
Online published on 19 June, 2014.
Polysorbate 80 (Tween 80®) is a commonly used media for solubilizing eugenol and thus could be employed as a solubilizer in the in vitro release studies of eugenol from its dosage forms. Till date no studies have been reported a validated UV spectrophotometric assay method for the estimation of eugenol in dissolution media containing Tween 80 as solubilizer. Towards this objective of quantification of eugenol efforts have been made towards the development and validation analytical method by UV spectrophotometry. The method was validated according to International Conference on Harmonisation (ICH) guidelines Q2(R1) with respect to linearity and range, precision, accuracy, detection limit (DL) and quantitation limit (QL). The detection limit and quantitation limit were determined as per the ICH guidelines and were found to be 0.62 and 1.88 μg mL−1 respectively. Thus it was confirmed that the developed method could be employed for the quantification of eugenol from 0.5% w/v aqueous Tween 80 solutions used as aqueous phase for in vitro release studies of eugenol loaded drug delivery systems.
ICH, Tween 80, dissolution, drug release, validation