Related substances test and characterization of seratrodast in bulk drugs
A reversed-phase high-performance liquid chromatographic (RP-HPLC) method for related substances test of seratrodast in bulk drugs has been developed. The separation was achieved on a ZirChrom Kromasil C<sub>18</sub> (200 mm×4.6 mm, 5 µm) column thermostated at 30 ºC using acetonitrile...
Guardado en:
| Autores principales: | , |
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| Formato: | Articulo |
| Lenguaje: | Inglés |
| Publicado: |
2011
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| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/8101 http://www.latamjpharm.org/resumenes/30/1/LAJOP_30_1_1_8.pdf |
| Aporte de: |
| id |
I19-R120-10915-8101 |
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| record_format |
dspace |
| institution |
Universidad Nacional de La Plata |
| institution_str |
I-19 |
| repository_str |
R-120 |
| collection |
SEDICI (UNLP) |
| language |
Inglés |
| topic |
Farmacia HPLC method; purity test; seratrodast related substances; structure characterization Cromatografia líquida de alta eficiencia Técnicas de Investigación Receptores de Tromboxanos |
| spellingShingle |
Farmacia HPLC method; purity test; seratrodast related substances; structure characterization Cromatografia líquida de alta eficiencia Técnicas de Investigación Receptores de Tromboxanos Xu, Jufang Hu, Yuzhu Related substances test and characterization of seratrodast in bulk drugs |
| topic_facet |
Farmacia HPLC method; purity test; seratrodast related substances; structure characterization Cromatografia líquida de alta eficiencia Técnicas de Investigación Receptores de Tromboxanos |
| description |
A reversed-phase high-performance liquid chromatographic (RP-HPLC) method for related
substances test of seratrodast in bulk drugs has been developed. The separation was achieved on a
ZirChrom Kromasil C<sub>18</sub> (200 mm×4.6 mm, 5 µm) column thermostated at 30 ºC using acetonitrile-0.05 M
pH 3.0 potassium dihydrogen orthophosphate buffer (60:40, v/v) as a mobile phase. Wavelength was set at
267 nm. An external standard method using a dilution of the sample solution as reference was used for the
purity test. The method was found to be simple, rapid, specific and sensitive with detection limit of 0.67 ng.
A thorough study has been undertaken to identify and characterize an unknown impurity at a level over
the identification threshold of 0.1 %, and its structure was elucidated as 7-(3,5,6-trimethyl-1,4-benzoquinone-
2-yl)-7-p-tolyl-heptanoic acid based on the data of MS, UV, IR and NMR spectra. Formation of
the unknown impurity as well as the countermeasure was also discussed |
| format |
Articulo Articulo |
| author |
Xu, Jufang Hu, Yuzhu |
| author_facet |
Xu, Jufang Hu, Yuzhu |
| author_sort |
Xu, Jufang |
| title |
Related substances test and characterization of seratrodast in bulk drugs |
| title_short |
Related substances test and characterization of seratrodast in bulk drugs |
| title_full |
Related substances test and characterization of seratrodast in bulk drugs |
| title_fullStr |
Related substances test and characterization of seratrodast in bulk drugs |
| title_full_unstemmed |
Related substances test and characterization of seratrodast in bulk drugs |
| title_sort |
related substances test and characterization of seratrodast in bulk drugs |
| publishDate |
2011 |
| url |
http://sedici.unlp.edu.ar/handle/10915/8101 http://www.latamjpharm.org/resumenes/30/1/LAJOP_30_1_1_8.pdf |
| work_keys_str_mv |
AT xujufang relatedsubstancestestandcharacterizationofseratrodastinbulkdrugs AT huyuzhu relatedsubstancestestandcharacterizationofseratrodastinbulkdrugs |
| bdutipo_str |
Repositorios |
| _version_ |
1764820488011382785 |