Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules

• Autor(a) principal: Bonfilio, Rudy
• Data de Publicação: 2009
• Outros Autores: Teixeira Tarley, Cesar Ricardo, Pereira, Gislaine Ribeiro, Salgado, Hérida Regina Nunes [UNESP], de Araujo, Magali Benjamim
• Tipo de documento: Artigo de conferência
• Idioma: eng
• Título da fonte: Repositório Institucional da UNESP
• Texto Completo: http://dx.doi.org/10.1016/j.talanta.2009.06.060; http://hdl.handle.net/11449/7835
• topic: Doehlert design; Fractional factorial design; Losartan potassium; Reversed-phase chromatography; Validation

This paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2: 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6 mm W., 5 mu m) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%). selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug. (C) 2009 Elsevier B.V. All rights reserved.