Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique

The objective of reducing analysis time and maintaining good efficiency, there has been substantial focus on high-speed chromatographic separations. Recently, commercially available ultra performance liquid chromatography (UPLC) has proven to be one of the most promising developments in the area of...

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Detalles Bibliográficos
Autores principales:	Patel, Pratibha, Sahu, Kapendra, Karthikeyan, Chandrabose, Moorthy, N.S.H.N., Trivedi, Piyush
Formato:	Articulo
Lenguaje:	Inglés
Publicado:	2011
Materias:	Farmacia Cromatografía Liquida degradation; salmeterol xinafoate; stability indicating assay; stress testing; UPLC; validation Agentes Antiinflamatorios Estabilidad de Medicamentos
Acceso en línea:	http://sedici.unlp.edu.ar/handle/10915/8247 http://www.latamjpharm.org/resumenes/30/5/LAJOP_30_5_1_23.pdf
Aporte de:	SEDICI (UNLP) de Universidad Nacional de La Plata

id	I19-R120-10915-8247
record_format	dspace
institution	Universidad Nacional de La Plata
institution_str	I-19
repository_str	R-120
collection	SEDICI (UNLP)
language	Inglés
topic	Farmacia Cromatografía Liquida degradation; salmeterol xinafoate; stability indicating assay; stress testing; UPLC; validation Agentes Antiinflamatorios Estabilidad de Medicamentos
spellingShingle	Farmacia Cromatografía Liquida degradation; salmeterol xinafoate; stability indicating assay; stress testing; UPLC; validation Agentes Antiinflamatorios Estabilidad de Medicamentos Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Moorthy, N.S.H.N. Trivedi, Piyush Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
topic_facet	Farmacia Cromatografía Liquida degradation; salmeterol xinafoate; stability indicating assay; stress testing; UPLC; validation Agentes Antiinflamatorios Estabilidad de Medicamentos
description	The objective of reducing analysis time and maintaining good efficiency, there has been substantial focus on high-speed chromatographic separations. Recently, commercially available ultra performance liquid chromatography (UPLC) has proven to be one of the most promising developments in the area of fast chromatographic separations. In this work, a new isocratic reverse phase chromatographic stability indicating assay method was developed using UPLC for salmeterol xinafoate bulk drug. A novel stability-indicating UPLC assay method was developed and validated for salmeterol xinafoate and its degradation products. An isocratic UPLC method was developed to separate the drug from the degradation products, using an Acquity UPLC BEH C18 (50 mm x 2.1 mm column). Mixture of methanol: 0.06 % and pH 3.4 ammonium acetate (65:35) was used as mobile phase. The flow rate was kept 0.6 mL/min and the detection was carried out at 228 nm. The linearity of the proposed method was investigated in the range of 10-50 μg/mL (r2 = 0.999) for salmeterol xinafoate. The method detection limit was 0.5 μg/mL and the method quantification limit was 1 μg/mL. The percentage recovery of salmeterol xinafoate was ranged from 97.2 to 99.5 %. The %RSD values for intra-day precision study were <1.0 % and for inter-day study were < 2.0 %, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate and robust.
format	Articulo Articulo
author	Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Moorthy, N.S.H.N. Trivedi, Piyush
author_facet	Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Moorthy, N.S.H.N. Trivedi, Piyush
author_sort	Patel, Pratibha
title	Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
title_short	Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
title_full	Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
title_fullStr	Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
title_full_unstemmed	Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique
title_sort	determination of salmeterol xinafoate and its degradation products according to ich guidelines with use of uplc technique
publishDate	2011
url	http://sedici.unlp.edu.ar/handle/10915/8247 http://www.latamjpharm.org/resumenes/30/5/LAJOP_30_5_1_23.pdf
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Determination of salmeterol xinafoate and its degradation products according to ICH guidelines with use of UPLC technique

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