title: Development and validation of an UHPLC method for the determination of betamethasone valerate in cream, gel, ointment and lotion.
abstract: An ultra high performance liquid chromatographic method has been developed and validated for the determination of betamethasone valerate (BMV) in topical dermatologic formulations. For the development of the method, response surface methodology based on a three-level full factorial design was used. The eluent composition, the column dimension and the flow rate were chosen as relevant experimental parameters to investigate. The response surface plots revealed an optimum separation by using a RP column (30 mm × 2 mm i.d., 2.2 μm particle size), at 30 °C; isocratic mobile phase consisting of acetonitrile:water (60:40) at a flow rate of 0.2 mL min(-1) and a wavelength set at 254 nm. The proposed method was validated for four types of matrices according to ICH guidelines requirements. Dexamethasone acetate (DMA) was used as internal standard. Linearity was studied in the range of 5-200 μg mL(-1) for BMV in spiked matrix samples. Recoveries were in the range of 95-105% and precision was better than 5% for both analytes, either in cream, gel, ointment, or lotion formulations, when using simple sample preparation. Retention times were 0.95 min for DMA and 1.40 min for BMV, demonstrating a short method run time. The method was successfully applied for routine analysis of dermatological formulations containing betamethasone valerate.
authors.affiliation: Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Laboratório de Controle de Qualidade de Medicamentos, Rua General Gustavo Cordeiro de Faria, S/N, 59012-570 Natal, RN, Brazil.
authors.forename: Lílian Grace da Silva
authors.initials: LG
authors.lastname: Solon
authors.affiliation: Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Laboratório de Controle de Qualidade de Medicamentos, Rua General Gustavo Cordeiro de Faria, S/N, 59012-570 Natal, RN, Brazil.
authors.forename: Igor Prado de Barros
authors.initials: IP
authors.lastname: Lima
authors.affiliation: Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Laboratório de Controle de Qualidade de Medicamentos, Rua General Gustavo Cordeiro de Faria, S/N, 59012-570 Natal, RN, Brazil.
authors.forename: Fernando Henrique Andrade
authors.initials: FH
authors.lastname: Nogueira
authors.affiliation: Departamento de Estatística, Laboratório de Estatística Aplicada, Universidade Federal do Rio Grande do Norte, Caixa Postal 1524, Campus Universitário Lagoa Nova, 59078-970 Natal, RN, Brazil.
authors.forename: Jailton Paulo
authors.initials: JP
authors.lastname: de Araújo
authors.affiliation: Departamento de Estatística, Laboratório de Estatística Aplicada, Universidade Federal do Rio Grande do Norte, Caixa Postal 1524, Campus Universitário Lagoa Nova, 59078-970 Natal, RN, Brazil.
authors.forename: Carla Almeida
authors.initials: CA
authors.lastname: Vivacqua
authors.affiliation: Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Laboratório de Controle de Qualidade de Medicamentos, Rua General Gustavo Cordeiro de Faria, S/N, 59012-570 Natal, RN, Brazil. Electronic address: cicero.aragao@yahoo.com.br.
authors.forename: Cícero Flávio Soares
authors.initials: CF
authors.lastname: Aragão
mesh_terms: D053000:Analytic Sample Preparation Methods; D001624:Betamethasone Valerate / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004339:Drug Compounding; D005782:Gels; D009824:Ointments; D063465:Skin Cream / Q000737:chemistry*
chemical_list: D005782:Gels; D009824:Ointments; D001624:Betamethasone Valerate
keywords: Betamethasone valerate; Dermatologic formulations; DoE; Three-level factorial design; UHPLC