Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay

An ultraviolet (UV) spectrophotometric method was developed for the analysis of telithromycin, member of the ketolides, in drug substance and coated tablets. The method validation yielded good results, such as the range, linearity, intra and inter-day precision, accuracy, recovery specificity, and r...

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Autores principales: Vaucher, Lauren C., Paim, Clésio S., Lange, Alini D., Schapoval, Elfrides E. S.
Formato: Articulo Comunicacion
Lenguaje:Inglés
Publicado: 2011
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8124
http://www.latamjpharm.org/resumenes/30/1/LAJOP_30_1_2_8.pdf
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id I19-R120-10915-8124
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
quality control; spectrophotometry; telithromycin
antibiótico
Espectrofotometría Ultravioleta
spellingShingle Farmacia
quality control; spectrophotometry; telithromycin
antibiótico
Espectrofotometría Ultravioleta
Vaucher, Lauren C.
Paim, Clésio S.
Lange, Alini D.
Schapoval, Elfrides E. S.
Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
topic_facet Farmacia
quality control; spectrophotometry; telithromycin
antibiótico
Espectrofotometría Ultravioleta
description An ultraviolet (UV) spectrophotometric method was developed for the analysis of telithromycin, member of the ketolides, in drug substance and coated tablets. The method validation yielded good results, such as the range, linearity, intra and inter-day precision, accuracy, recovery specificity, and robustness. UV spectrophotometric determinations were performed at 258 nm. Good linearity was obtained between 10.0 and 70.0/ μg mL. A prospective validation showed that the method is linear (r = 1) with precise relative standard deviation (RSD) of 0.4 %. The intra and inter-day precision values were < 2 % for all samples analyzed. The comparison between UV spectrophotometric, high performance liquid chromatography (HPLC) and microbiological assay showed no significant difference between the methodologies. The proposed method is appropriate for the determination of telithromycin in tablets and can be used in routine quality control
format Articulo
Comunicacion
author Vaucher, Lauren C.
Paim, Clésio S.
Lange, Alini D.
Schapoval, Elfrides E. S.
author_facet Vaucher, Lauren C.
Paim, Clésio S.
Lange, Alini D.
Schapoval, Elfrides E. S.
author_sort Vaucher, Lauren C.
title Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
title_short Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
title_full Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
title_fullStr Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
title_full_unstemmed Validation of UV spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with HPLC and microbiological assay
title_sort validation of uv spectrophotometric method for telithromycin in pharmaceutical formulations and comparison with hplc and microbiological assay
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8124
http://www.latamjpharm.org/resumenes/30/1/LAJOP_30_1_2_8.pdf
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