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2014 | 12 | 5 | 549-556
Tytuł artykułu

Development and validation of an intrinsic dissolution method for nimodipine polymorphs

Treść / Zawartość
Warianty tytułu
Języki publikacji
EN
Abstrakty
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.
Słowa kluczowe
Wydawca

Czasopismo
Rocznik
Tom
12
Numer
5
Strony
549-556
Opis fizyczny
Daty
wydano
2014-05-01
online
2014-02-21
Twórcy
  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of Santa Catarina
  • Federal University of São Paulo
Bibliografia
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Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.-psjd-doi-10_2478_s11532-014-0511-9
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