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Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide

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Аутори
Sljivić, Jasmina
Protić, Ana
Otašević, Biljana
Golubović, Jelena
Zečević, Mira
Krmar, Jovana
Чланак у часопису (Објављена верзија)
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Апстракт
Multicriteria optimization methodology was applied in development of UHPLC-UV-MS method for separation of cilazapril, hydrochlorothiazide and their degradation products. This method is also applicable for analysis of cilazapril, hydrochlorothiazide and their degradation products in combined tablet formulation. Prior to method optimization forced degradation studies were conducted. Cilazapril and hydrochlorothiazide were subjected to acidic (0.1, 0.5 and 1.0M HCl), basic (0.1, 0.5 and 1.0M NaOH), thermal (70 degrees C), oxidative (3-30% H2O2) degradation and photodegradation (day light). Cilazapril appeared to be unstable toward acid and base and resulted in formation of cilazaprilat. Hydrochlorothiazide significantly degraded after acid, base and thermal hydrolysis and formed degradation product was 4-amino-6-chlorobenzene-1.3-disulfonamide. For both substances, after oxidative degradation unknown products have arisen. Initial percentage of acetonitrile in mobile phase, final percentag...e of acetonitrile in mobile phase, time of gradient elution and column temperature were defined as variables to be optimized toward two chromatographic responses by means of central composite design and Derringer's desirability function. The satisfactory chromatographic analysis was achieved on Kinetex C18 (2.6 mu m, 50 x 2.1 mm) column with temperature set at 25 degrees C. The final mobile phase consisted of acetonitrile and 20mM ammonium formate buffer (pH adjusted to 8.5). The flow rate of the mobile phase was 400 mu L min(-1) and it was pumped in a gradient elution mode.

Извор:
Journal of Chromatographic Science, 2017, 55, 6, 625-637
Издавач:
  • Oxford Univ Press Inc, Cary
Пројекти:
  • Синтеза, квантитативни однос између структуре и дејства, физичко-хемијска карактеризација и анализа фармаколошки активних супстанци (RS-172033)

DOI: 10.1093/chromsci/bmx018

ISSN: 0021-9665

PubMed: 28334985

WoS: 000404619700006

Scopus: 2-s2.0-85024406870
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2905
Колекције
  • Radovi istraživača / Researchers’ publications
Институција
Pharmacy

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