Stability Indicating HPTLC and LC Determination of Dasatinib in Pharmaceutical Dosage Form |
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Authors: | D V Mhaske S R Dhaneshwar |
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Institution: | (1) Department of Quality Assurance Techniques and Pharm. Chem., Bharati Vidyapeeth University, Centre for Advanced Pharmaceutical Research, Erandwane, Pune, 411038, Maharashtra, India |
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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. |
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Keywords: | Column liquid chromatography Thin layer chromatography Method validation and degradation Dasatinib |
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