Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets

A simple UV-spectrophotometric method was developed and validated for the analysis and dissolution studies of sitagliptin phosphate in tablets. Specificity test indicated an adequate UV detection at 267 nm. The method was validated regarding Specificity/accuracy/precision (RSD < 2 %), linearity (...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Ravanello, Aline, Dadalt, Gabriele, Torres, Bruna G. S., Hurtado, Felipe K., Marcolino, Ana I. P., Rolim, Clarice M. B.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2010
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8011
http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_1_16.pdf
Aporte de:
id I19-R120-10915-8011
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
dissolution; sitagliptin; UV-spectrophotometry; validation
Farmacología
Espectrofotometría
Medicamentos
Evaluación de drogas
spellingShingle Farmacia
dissolution; sitagliptin; UV-spectrophotometry; validation
Farmacología
Espectrofotometría
Medicamentos
Evaluación de drogas
Ravanello, Aline
Dadalt, Gabriele
Torres, Bruna G. S.
Hurtado, Felipe K.
Marcolino, Ana I. P.
Rolim, Clarice M. B.
Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
topic_facet Farmacia
dissolution; sitagliptin; UV-spectrophotometry; validation
Farmacología
Espectrofotometría
Medicamentos
Evaluación de drogas
description A simple UV-spectrophotometric method was developed and validated for the analysis and dissolution studies of sitagliptin phosphate in tablets. Specificity test indicated an adequate UV detection at 267 nm. The method was validated regarding Specificity/accuracy/precision (RSD < 2 %), linearity (r2 = 0.9999), and partial robustness. Tablets uniformity was 102.52 % (RSD = 2.54 %). The method was applied for the determination of the drug in commercial tablet preparations and proved to be reliable for quantification It was also used for the comparison of dissolution profiles of sitagliptin tablets. After dissolution tests comparing eight different conditions through dissolution efficiency (DE), the chosen condition for posterior tests was USP apparatus 1 (basket) in 0.01M HCl pH 3.0, at a stirring rate of 50 rpm. The methodology was applied to two batches of sitagliptin phosphate tablets, giving similar dissolution profiles compared by the difference and similarity factor, obtaining values within the specified limits.
format Articulo
Articulo
author Ravanello, Aline
Dadalt, Gabriele
Torres, Bruna G. S.
Hurtado, Felipe K.
Marcolino, Ana I. P.
Rolim, Clarice M. B.
author_facet Ravanello, Aline
Dadalt, Gabriele
Torres, Bruna G. S.
Hurtado, Felipe K.
Marcolino, Ana I. P.
Rolim, Clarice M. B.
author_sort Ravanello, Aline
title Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
title_short Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
title_full Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
title_fullStr Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
title_full_unstemmed Development and validation of an UV-spectrophotometric method for the dissolution studies of sitagliptin tablets
title_sort development and validation of an uv-spectrophotometric method for the dissolution studies of sitagliptin tablets
publishDate 2010
url http://sedici.unlp.edu.ar/handle/10915/8011
http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_1_16.pdf
work_keys_str_mv AT ravanelloaline developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
AT dadaltgabriele developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
AT torresbrunags developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
AT hurtadofelipek developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
AT marcolinoanaip developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
AT rolimclaricemb developmentandvalidationofanuvspectrophotometricmethodforthedissolutionstudiesofsitagliptintablets
bdutipo_str Repositorios
_version_ 1764820487617118209