Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC

The present research work describes comprehensive stress testing of eprosartan mesylate (EM) according to ICH guideline Q1A (R2), and development of a stability-indicating reversed phase ultra performance liquid chromatographic (UPLC) assay. The drug was subjected to acid (0.5N HCl), neutral and alk...

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Autores principales:	Patel, Pratibha, Sahu, Kapendra, Karthikeyan, Chandrabose, Hari Narayana Moorthy, N. S., Trivedi, Piyush
Formato:	Articulo
Lenguaje:	Inglés
Publicado:	2011
Materias:	Farmacia Técnicas de Química Analítica eprosartan mesylate; stress testing; stability indicating assay; validation; UPLC Compuestos Orgánicos
Acceso en línea:	http://sedici.unlp.edu.ar/handle/10915/8199 http://www.latamjpharm.org/resumenes/30/4/LAJOP_30_4_1_7.pdf
Aporte de:	SEDICI (UNLP) de Universidad Nacional de La Plata

id	I19-R120-10915-8199
record_format	dspace
institution	Universidad Nacional de La Plata
institution_str	I-19
repository_str	R-120
collection	SEDICI (UNLP)
language	Inglés
topic	Farmacia Técnicas de Química Analítica eprosartan mesylate; stress testing; stability indicating assay; validation; UPLC Compuestos Orgánicos
spellingShingle	Farmacia Técnicas de Química Analítica eprosartan mesylate; stress testing; stability indicating assay; validation; UPLC Compuestos Orgánicos Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Hari Narayana Moorthy, N. S. Trivedi, Piyush Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
topic_facet	Farmacia Técnicas de Química Analítica eprosartan mesylate; stress testing; stability indicating assay; validation; UPLC Compuestos Orgánicos
description	The present research work describes comprehensive stress testing of eprosartan mesylate (EM) according to ICH guideline Q1A (R2), and development of a stability-indicating reversed phase ultra performance liquid chromatographic (UPLC) assay. The drug was subjected to acid (0.5N HCl), neutral and alkaline (0.5 N NaOH) hydrolytic conditions at 80 °C, and to oxidative decomposition at room temperature. Photolysis was carried out by exposing the drug during the day time to sunlight (60,000-70,000 lux) for two days and oxidative study was performed with 0.5 mg/ml in 30 % hydrogen peroxide (H<sub>2</sub>O<sub>2</sub> ) at room temperature for 25 hr. The solid drug was also subjected to 50 °C for 30 days in a hot air oven. Degradation of the drug was found to occur under alkaline, acidic and neutral hydrolytic conditions. Separation of the drug and the degradation products was successfully achieved on a BEH (bridged ethylene hybrid) C18 column (1.7 µm, 2.1 mm × 150 mm) with gradient elution of water-acetonitrile as mobile phase. The flow rate and detection wavelength were 0.1 ml/min and 232 nm, respectively. The method was validated and the response was found to be linear in the drug concentration range 5-25 µg/ml (r<sup>2</sup> = 0.999). The %RSD in intra-day and inter-day precision studies was < 0.8 %. Recovery of the drug from a mixture of degradation products was between 98.3 and 99.8 %. The LOD and LOQ of developed method were obtained at 0.15 µg/ml and 0.45 µg/ml respectively. The method was specific to the drug, selective to degradation products, and robust. PDA purity test also confirmed the specificity of the method.
format	Articulo Articulo
author	Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Hari Narayana Moorthy, N. S. Trivedi, Piyush
author_facet	Patel, Pratibha Sahu, Kapendra Karthikeyan, Chandrabose Hari Narayana Moorthy, N. S. Trivedi, Piyush
author_sort	Patel, Pratibha
title	Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
title_short	Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
title_full	Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
title_fullStr	Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
title_full_unstemmed	Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC
title_sort	study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by uplc
publishDate	2011
url	http://sedici.unlp.edu.ar/handle/10915/8199 http://www.latamjpharm.org/resumenes/30/4/LAJOP_30_4_1_7.pdf
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Study of forced degradation behaviour of eprosartan mesylate and development of validated stability indicating assay method by UPLC

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