Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. Ezetimibe was separated in a 100 x 4.6 mm i.d., C18 column, 3 um particle size, Luna phenomenex, using a mobile phase composition of wate...

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Autores principales: Nakarani, Mahendra P., Patel, Priyal R., Patel, Jayavdan K., Vaghani, Subhash S.
Formato: Articulo
Lenguaje:Español
Publicado: 2011
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8233
http://www.latamjpharm.org/resumenes/30/5/LAJOP_30_5_1_9.pdf
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id I19-R120-10915-8233
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Español
topic Farmacia
Cromatografía Líquida de Alta Presión
medicamento
ezetimibe; RP-HPLC; self emulsifying drug delivery
Formas de Dosificación
Placebos
Colesterol
spellingShingle Farmacia
Cromatografía Líquida de Alta Presión
medicamento
ezetimibe; RP-HPLC; self emulsifying drug delivery
Formas de Dosificación
Placebos
Colesterol
Nakarani, Mahendra P.
Patel, Priyal R.
Patel, Jayavdan K.
Vaghani, Subhash S.
Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
topic_facet Farmacia
Cromatografía Líquida de Alta Presión
medicamento
ezetimibe; RP-HPLC; self emulsifying drug delivery
Formas de Dosificación
Placebos
Colesterol
description In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. Ezetimibe was separated in a 100 x 4.6 mm i.d., C18 column, 3 um particle size, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25 °C. The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.
format Articulo
Articulo
author Nakarani, Mahendra P.
Patel, Priyal R.
Patel, Jayavdan K.
Vaghani, Subhash S.
author_facet Nakarani, Mahendra P.
Patel, Priyal R.
Patel, Jayavdan K.
Vaghani, Subhash S.
author_sort Nakarani, Mahendra P.
title Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
title_short Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
title_full Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
title_fullStr Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
title_full_unstemmed Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms
title_sort development and validation of stability indicating rp-hplc method for the determination of ezetimibe in pharmaceutical dosage forms
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8233
http://www.latamjpharm.org/resumenes/30/5/LAJOP_30_5_1_9.pdf
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