Stability-indicating method for the analysis of amorolfine and its N-oxide degradation product

Authors

  • Rafaela Zimmermann Graduate Program in Pharmaceutical Sciences, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752, 90610-000 Porto Alegre – RS, Brazil
  • Fernanda Battisti Graduate Program in Pharmaceutical Sciences, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752, 90610-000 Porto Alegre – RS, Brazil
  • Pamela Lukasewicz Graduate Program in Pharmaceutical Sciences, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752, 90610-000 Porto Alegre – RS, Brazil
  • Saulo Andrade Graduate Program in Pharmaceutical Sciences, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752, 90610-000 Porto Alegre – RS, Brazil
  • Diogo Miron Faculdade de Farmácia - Universidade Federal do Rio Grande do SUL http://orcid.org/0000-0003-1415-9461
  • Elfrides Schapoval Graduate Program in Pharmaceutical Sciences, Universidade Federal do Rio Grande do Sul, Av. Ipiranga 2752, 90610-000 Porto Alegre – RS, Brazil

DOI:

https://doi.org/10.22456/2527-2616.128737

Keywords:

Amorolfine, N-oxide, HPLC, mass spectrometry, Loceryl

Abstract

This work aimed to validate a stability-indicating method for determining amorolfine (AMF) in topical formulations by HPLC-DAD. The tailing factor, capacity factor, and theoretical plates were optimized by employing the desirability function. AMF was quantified in a hydrophilic formulation produced in our laboratory and Loceryl® cream and lacquer. Reverse-phase HPLC method with detection at 218 nm showed selectivity (peak purity> 995), robustness (RSD <2.0%), linearity (35–325 μg.mL-1), accuracy (≈100.0%), precision (RSD <2.0%) and limit of quantitation of 750 ng.mL-1. Forced degradation of AMF in an oxidative medium containing hydrogen peroxide resulted in a degradation product that was purified and identified as an N-oxide. The degradation kinetics was pH-dependent.

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Published

2023-07-26

How to Cite

Zimmermann, R., Battisti, F., Lukasewicz, P., Andrade, S., Miron, D., & Schapoval, E. (2023). Stability-indicating method for the analysis of amorolfine and its N-oxide degradation product. Drug Analytical Research, 7(1), 11–20. https://doi.org/10.22456/2527-2616.128737

Issue

Vol. 7 No. 1 (2023)

Section

ORIGINAL ARTICLES

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