title: Stability-indicating LC assay for butenafine hydrochloride in creams using an experimental design for robustness evaluation and photodegradation kinetics study.
abstract: A stability-indicating liquid chromatography method for the determination of the antifungal agent butenafine hydrochloride (BTF) in a cream was developed and validated using the Plackett-Burman experimental design for robustness evaluation. Also, the drug photodegradation kinetics was determined. The analytical column was operated with acetonitrile, methanol and a solution of triethylamine 0.3% adjusted to pH 4.0 (6:3:1) at a flow rate of 1 mL/min and detection at 283 nm. BTF extraction from the cream was done with n-butyl alcohol and methanol in ultrasonic bath. The performed degradation conditions were: acid and basic media with HCl 1M and NaOH 1M, respectively, oxidation with H(2)O(2) 10%, and the exposure to UV-C light. No interference in the BTF elution was verified. Linearity was assessed (r(2) = 0.9999) and ANOVA showed non-significative linearity deviation (p > 0.05). Adequate results were obtained for repeatability, intra-day precision, and accuracy. Critical factors were selected to examine the method robustness with the two-level Plackett-Burman experimental design and no significant factors were detected (p > 0.05). The BTF photodegradation kinetics was determined for the standard and for the cream, both in methanolic solution, under UV light at 254 nm. The degradation process can be described by first-order kinetics in both cases.
authors.affiliation: Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Av. Ipiranga 2752, Porto Alegre-RS, Brazil. alinebbarth@hotmail.com
authors.forename: Aline Bergesch
authors.initials: AB
authors.lastname: Barth
authors.forename: Gabriela Bolfe
authors.initials: GB
authors.lastname: de Oliveira
authors.forename: Marcelo Donadel
authors.initials: MD
authors.lastname: Malesuik
authors.forename: Clésio Soldatelli
authors.initials: CS
authors.lastname: Paim
authors.forename: Nadia Maria
authors.initials: NM
authors.lastname: Volpato
mesh_terms: D000935:Antifungal Agents / Q000737:chemistry*; D001596:Benzylamines / Q000737:chemistry*; D002853:Chromatography, Liquid / Q000379:methods*; D004304:Dosage Forms; D004355:Drug Stability; D007700:Kinetics; D009281:Naphthalenes / Q000737:chemistry*; D010782:Photolysis
chemical_list: D000935:Antifungal Agents; D001596:Benzylamines; D004304:Dosage Forms; D009281:Naphthalenes; C067594:butenafine