Abstract

Efavirenz-loaded polymeric nanocapsules: Formulation, development, and validation of an RP-UHPLC-DAD method for drug quantification, determination of encapsulation efficiency, stability study, and dissolution profile

Highlights

  • Polymeric nanocapsules have been recognized as promising drug carrier systems and the use of efavirenz (EFV)loaded delivery systems is a suitable strategy for the treatment of acquired immunodeficiency syndrome, as these formulations can improve the dissolution profile, prolong the pharmacological effect, lead to a decrease in dosage, and, reduce side effects (Dimer et al, 2020; Lyra et al, 2017; Patel et al, 2013; Varshosaz et al, 2018)

  • This study aims at preparing efavirenz (EFV)-loaded polymeric nanocapsules and carrying out the analytical method development and validation in order to provide a suitable tool for evaluating these formulations in terms of encapsulation efficiency, stability, and dissolution profile

  • To the best of our knowledge, this is the first report about the stability of polymeric nanoformulations containing EFV.Taking all these into account, this study aimed to obtain EFV-loaded nanocapsules based on poly(ε-caprolactone) (PCL) and [poly(ethylene glycol) 6000] (PEG) and to describe the validation of a rapid UHPLC assay for the EFV determination in these formulations

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Summary

Introduction

Polymeric nanocapsules have been recognized as promising drug carrier systems and the use of efavirenz (EFV)loaded delivery systems is a suitable strategy for the treatment of acquired immunodeficiency syndrome, as these formulations can improve the dissolution profile, prolong the pharmacological effect, lead to a decrease in dosage, and, reduce side effects (Dimer et al, 2020; Lyra et al, 2017; Patel et al, 2013; Varshosaz et al, 2018). Induri et al (2016) validated a UHPLC-photodiode array detector (DAD) method for simultaneous quantification of EFV and lamivudine in tablets using a mobile phase containing 10 mM phosphate buffer (pH = 4.0) and 10.0% acetonitrile in methanol. Dos Santos Martins et al (2020) reported a validation method for EFV determination in plasma by UHPLC-DAD This method involved the addition of the plasma precipitation using acetonitrile and solvent evaporation. No paper is provided by literature regarding the validation of a UHPLC method to determine EFV in polymeric nanocapsules by a fast and simple UHPLC method

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