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Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules.
Talanta. 2009 Nov 15; 80(1):236-41.T

Abstract

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 4.6mm i.d., 5 microm) 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.

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Authors+Show Affiliations

Bonfilio R
Departamento de Farmácia, Universidade Federal de Alfenas, 37130-000 Alfenas, MG, Brazil. rudybonfilio@yahoo.com.br
Tarley CR
No affiliation info available
Pereira GR
No affiliation info available
Salgado HR
No affiliation info available
de Araújo MB
No affiliation info available

MeSH

Angiotensin II Type 1 Receptor BlockersCapsulesChromatography, High Pressure LiquidHydrogen-Ion ConcentrationLosartanMultivariate AnalysisReproducibility of ResultsTechnology, PharmaceuticalTemperature

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19782220

Citation

Bonfilio, Rudy, et al. "Multivariate Optimization and Validation of an Analytical Methodology By RP-HPLC for the Determination of Losartan Potassium in Capsules." Talanta, vol. 80, no. 1, 2009, pp. 236-41.
Bonfilio R, Tarley CR, Pereira GR, et al. Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules. Talanta. 2009;80(1):236-41.
Bonfilio, R., Tarley, C. R., Pereira, G. R., Salgado, H. R., & de Araújo, M. B. (2009). Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules. Talanta, 80(1), 236-41. https://doi.org/10.1016/j.talanta.2009.06.060
Bonfilio R, et al. Multivariate Optimization and Validation of an Analytical Methodology By RP-HPLC for the Determination of Losartan Potassium in Capsules. Talanta. 2009 Nov 15;80(1):236-41. PubMed PMID: 19782220.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules. AU - Bonfilio,Rudy, AU - Tarley,César Ricardo Teixeira, AU - Pereira,Gislaine Ribeiro, AU - Salgado,Hérida Regina Nunes, AU - de Araújo,Magali Benjamim, Y1 - 2009/07/04/ PY - 2009/04/16/received PY - 2009/06/02/revised PY - 2009/06/27/accepted PY - 2009/9/29/entrez PY - 2009/9/29/pubmed PY - 2010/1/19/medline SP - 236 EP - 41 JF - Talanta JO - Talanta VL - 80 IS - 1 N2 - 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 4.6mm i.d., 5 microm) 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. SN - 1873-3573 UR - https://www.unboundmedicine.com/medline/citation/19782220/Multivariate_optimization_and_validation_of_an_analytical_methodology_by_RP_HPLC_for_the_determination_of_losartan_potassium_in_capsules_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0039-9140(09)00536-0 DB - PRIME DP - Unbound Medicine ER -