Abstract

METHOD DEVELOPMENT AND VALIDATION OF BOSENTAN IN BULK AND PHARMACEUTICAL FORMULATION BY USING HPTLC

Lakshmi Madhuri B., Savita Yadav, Chaitali Dhale and Janhavi Rao*

ABSTRACT

In the present study a rapid specific economical HPTLC method has been developed for determination of Bosentan in bulk and pharmaceutical dosage formulation. Chromatographic separation was achieved on aluminum plates precoated with silica gel 60 F254 aluminum plates with mobile phase of methanol: toluene in the ratio of 2: 8(v/v). Detection was performed densitometrically at 225 nm using Camag TLC Scanner. The Rf of Bosentan found to be 0.32.The Method was validated as per ICH guidelines in terms of linearity (40- 400 ng/band), precision (intra-day variation 0.4, inter-day variation 0.3), accuracy (99.04 to100.6%) and specificity. The limit of detection and limit of quantification for Bosentan were found to be 10 ng/spot and 30 ng/spot, respectively. The method can be used as routine analysis of Bosentan in pharmaceutical formulation.

Keywords: Thin layer chromatography, Densitometry, Validation, Bosentan.