Sensitive RP-HPLC method of rivastigmine for applicative quantification of nanostructured lipid carriers

Abstract

The present research work focuses on development of a rapid, simple, precise, accurate and robust RP-HPLC method for quantitative estimation of rivastigmine hydrogen tartrate (RIV-HT) in bulk and formulations. Systematic optimization of the method observed two critical parameters, viz. pH of mobile phase and mobile phase ratio that particularly affected peak area, tailing factor and number of theoretical plates. The optimized mobile phase consisted of ACN (0.05 % v/v triethylamine): 10 mM, pH 5.5 phosphate buffer: IPA (33:65:2 v/v). The limit of detection and limit of quantification values were observed to be 7.32 and 24.15 ng/mL, with a linearity range between 25-600 ng/mL. The proposed method was observed to be specific in presence of solution and solid-state stress conditions. It was also specific in the presence of formulation excipients, release and permeation medium. The method was applied to estimate encapsulation efficiency, in-vitro release profiles, and ex-vivo nasal permeation efficiency of RIV-HT loaded nanostructured lipid carriers. The obtained results advocate that the newly proposed method is sensitive compared to the previously published reports and can be explicitly utilized for estimating RIV-HT in bulk and nanoformulations.