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| Content Provider | Springer Nature Link |
|---|---|
| Author | Mhaske, D. V. Dhaneshwar, S. R. |
| Copyright Year | 2007 |
| Abstract | Two sensitive and reproducible methods are described for the quantitative determination of dasatinib in the presence of its degradation products. The first method was based on high performance thin layer chromatography (HPTLC) followed by densitometric measurements of their spots at 280 nm. The separation was on HPTLC aluminium sheets of silica gel 60 F254 using toluene:chloroform (7.0:3.0, v/v). This system was found to give compact spots for dasatinib after development (R F value of 0.23 ± 0.02). The second method was based on high performance liquid chromatography (HPLC) of the drug from its degradation products on reversed phase, PerfectSil column [C18 (5 μm, 25 cm × 4.6 mm, i.d.)] at ambient temperature using mobile phase consisting of methanol:20 mM ammonium acetate with acetic acid (45:55, v/v) pH 3.0 and retention time (t R = 8.23 ± 0.02 min). Both separation methods were validated as per the ICH guidelines. No chromatographic interference from the tablet excipients was found. Dasatinib was subjected to acid–alkali hydrolysis, oxidation, dry heat, wet heat and photo-degradation. The drug was susceptible to acid–alkali hydrolysis and oxidation. The drug was found to be stable in neutral, wet heat, dry heat and photo-degradation conditions. As the proposed analytical methods could effectively separate the drug from its degradation products, they can be employed as stability indicating. |
| Starting Page | 95 |
| Ending Page | 102 |
| Page Count | 8 |
| File Format | |
| ISSN | 00095893 |
| Journal | Chromatographia |
| Volume Number | 66 |
| Issue Number | 1-2 |
| e-ISSN | 16121112 |
| Language | English |
| Publisher | Vieweg Verlag |
| Publisher Date | 2007-06-06 |
| Publisher Place | Wiesbaden |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Column liquid chromatography Thin layer chromatography Method validation and degradation Dasatinib Measurement Science, Instrumentation Plant Sciences Biochemistry Pharmacy Organic Chemistry Analytical Chemistry |
| Content Type | Text |
| Resource Type | Article |
| Subject | Organic Chemistry Analytical Chemistry Biochemistry Clinical Biochemistry |
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