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Journal
2014 | 12 | 5 | 549-556
Article title

Development and validation of an intrinsic dissolution method for nimodipine polymorphs

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Abstracts
EN
The polymorphs of nimodipine, Modification I (Mod I), the metastable racemate, and Modification II (Mod II), the stable conglomerate, were evaluated by means of the intrinsic dissolution procedure. For this purpose, a hydro alcoholic solution (ethanol:water, 50:50, v/v) was selected as the dissolution medium, maintained at 37±0.5°C. Different rotation speeds were tested (50, 75 and 100 rpm) and the lower one was chosen for the test validation. Although the sample initially characterized as polymorph Mod I presented higher intrinsic dissolution rates in all the conditions tested, no statistical differences were noticed between the two polymorphs. This result can be attributed to the partial solution-mediated phase transformation from Mod I to Mod II, detected through X-ray powder diffraction and differential scanning calorimetry. Also, reliable intrinsic dissolution rate data were acquired for the polymorph Mod II. The dissolution method was validated, being considered stable, specific, linear, sensible, accurate and precise.
Publisher

Journal
Year
Volume
12
Issue
5
Pages
549-556
Physical description
Dates
published
1 - 5 - 2014
online
21 - 2 - 2014
Contributors
  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of São Paulo
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Document Type
Publication order reference
Identifiers
YADDA identifier
bwmeta1.element.-psjd-doi-10_2478_s11532-014-0511-9
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