Development and validation of a HPTLC method for analysis of Sunitinib malate
Braz. j. pharm. sci
;
52(4): 595-601, Oct.-Dec. 2016. tab, graf
Article
Dans Anglais
| LILACS
| ID: biblio-951869
ABSTRACT
ABSTRACT A simple high performance thin layer chromatography (HPTLC) has been developed and validated for determination of sunitinib malate and possible impurities. The samples were applied in forms of bands on an aluminum TLC plate pre-coated with silica gel and were separated using dichloromethane methanol toluene ammonia solution as the mobile phase. Sunitinib malate was thoroughly separated from impurities including E-isomer, sunitinib N-oxide and impurity B with a retention factor (RF) of 0.35±0.02. Quantitative analysis of sunitinib was carried out using a mobile phase consisting of dichloromethanemethanolammonia solution, RF value was 0.53±0.02 for Z isomer. Detection was performed densitometrically in absorbance mode at 430 nm. This method was found to produce sharp, symmetrical, and well resolved peaks. Linear relationship with the coefficients of determination > 0.99 was achieved over the concentration range of 27.34 to 437.5 ng/spot. This method provides robust, replicable and accurate results with acceptable sensitivity.
Texte intégral:
Disponible
Indice:
LILAS (Amériques)
Sujet Principal:
Chromatographie
/
Anticarcinogènes
/
Études de validation
langue:
Anglais
Texte intégral:
Braz. j. pharm. sci
Année:
2016
Type:
Article
Pays d'affiliation:
Iran
Institution/Pays d'affiliation:
Tofigh Daru Research and Engineering Company/IR
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