Development and validation of a HPTLC method for analysis of Sunitinib malate
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...
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400595&lng=en&tlng=en |
| _version_ | 1818383341938802688 |
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| author | Monireh Hajmalek Masoumeh Goudarzi Solmaz Ghaffari Hossein Attar Mehrnoosh Ghanbari Mazlaghan |
| author_facet | Monireh Hajmalek Masoumeh Goudarzi Solmaz Ghaffari Hossein Attar Mehrnoosh Ghanbari Mazlaghan |
| author_sort | Monireh Hajmalek |
| collection | DOAJ |
| description | 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 dichloromethane:methanol:ammonia 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. |
| first_indexed | 2024-12-14T03:04:50Z |
| format | Article |
| id | doaj.art-888715f94f84436e83eb0793e81abac3 |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-14T03:04:50Z |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-888715f94f84436e83eb0793e81abac32022-12-21T23:19:25ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-979052459560110.1590/s1984-82502016000400003S1984-82502016000400595Development and validation of a HPTLC method for analysis of Sunitinib malateMonireh HajmalekMasoumeh GoudarziSolmaz GhaffariHossein AttarMehrnoosh Ghanbari MazlaghanABSTRACT 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 dichloromethane:methanol:ammonia 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400595&lng=en&tlng=enSunitinib malate/quantitative analysisHigh Performance Thin Layer Chromatography/method/validationSunitinib malate/E-Z isomer. |
| spellingShingle | Monireh Hajmalek Masoumeh Goudarzi Solmaz Ghaffari Hossein Attar Mehrnoosh Ghanbari Mazlaghan Development and validation of a HPTLC method for analysis of Sunitinib malate Brazilian Journal of Pharmaceutical Sciences Sunitinib malate/quantitative analysis High Performance Thin Layer Chromatography/method/validation Sunitinib malate/E-Z isomer. |
| title | Development and validation of a HPTLC method for analysis of Sunitinib malate |
| title_full | Development and validation of a HPTLC method for analysis of Sunitinib malate |
| title_fullStr | Development and validation of a HPTLC method for analysis of Sunitinib malate |
| title_full_unstemmed | Development and validation of a HPTLC method for analysis of Sunitinib malate |
| title_short | Development and validation of a HPTLC method for analysis of Sunitinib malate |
| title_sort | development and validation of a hptlc method for analysis of sunitinib malate |
| topic | Sunitinib malate/quantitative analysis High Performance Thin Layer Chromatography/method/validation Sunitinib malate/E-Z isomer. |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400595&lng=en&tlng=en |
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