TLC-densitometric method for quantitation of Lurasidone hydrochloride in nanoemulsion, microemulsion, for equilibrium solubility and ex vivo diffusion studies

Abstract

A new TLC-densitometric method has been successfully developed and validated for quantitation of Lurasidone hydrochloride in pharmaceutical formulations. The Lurasidone hydrochloride was well separated from sample matrix and degradation product using TLC plate; precoated with silica gel G 60F254 on aluminium sheet as a stationary phase and mixture of hexane: ethyl acetate (6:4 v/v) as a mobile phase. Lurasidone hydrochloride was quantified by densitometric analysis at 323 nm. The method was found to give compact bands for the drug (Rf = 0.47 ± 0.01). Linear regression analysis data for the calibration plots showed a good linear relationship in the concentration range of 100-600 ng. Statistical analysis of the data showed that the method is specific, precise, accurate, reproducible, and selective for the analysis of Lurasidone hydrochloride. The TLC-densitometric method was successfully applied in analysis of LURAH in solution, nanoemulsion, mucoadhesive nanoemulsion and microemulsion; subjected to stability testing under accelerated conditions of alkali, acid, thermal, photolytic and humidity. The method was successfully used for the determination of equilibrium solubility of Lurasidone hydrochloride in various excipents and ex vivo diffusion study through sheep nasal mucosa from in-house developed formulations.