Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF LEDIPASVIR

Santosh V. Gandhi* and Priyanka M. Pardeshi

ABSTRACT

The present work describes development and validation of a new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Ledipasvir as bulk drug and in synthetic mixture. As stability testing is major step with the development of new drug formulation, stress degradation studies were carried as per ICH guidelines. Chromatographic resolution of Ledipasvir and its degradation products was achieved by using precoated, silica gel 60 F-254 aluminium plates as stationary phase and Ethyl acetate: Methanol (9.5:0.5, v/v) as mobile phase. Densitometric scanning was carried out at 334 nm. The retention factor was found to be 0.31 ± 0.02. The developed method was validated with reference to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. Results found to be linear within the concentration range of 200-1200 ng/band. Ledipasvir was mainly found susceptible to acid, alkali hydrolysis as well as oxidation. The developed method has been successfully applied for the estimation of drug in synthetic mixture.

Keywords: Ledipasvir, HPTLC, Stability indicating, forced degradation, Method Development and Validation.