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...
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| Autores principales: | , |
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| Formato: | Articulo |
| Lenguaje: | Inglés |
| Publicado: |
2011
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| Materias: | |
| 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: |
| Sumario: | 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 |
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