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

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2017
2903.pdf (1.021Mb)
Authors
Sljivić, Jasmina
Protić, Ana
Otašević, Biljana
Golubović, Jelena
Zečević, Mira
Krmar, Jovana
Article (Published version)
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Abstract
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.

Source:
Journal of Chromatographic Science, 2017, 55, 6, 625-637
Publisher:
  • Oxford Univ Press Inc, Cary
Funding / projects:
  • Synthesis, Quantitative Structure and Activity Relationship, Physico-Chemical Characterisation and Analysis of Pharmacologically Active Substances (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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3
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2905
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Sljivić, Jasmina
AU  - Protić, Ana
AU  - Otašević, Biljana
AU  - Golubović, Jelena
AU  - Zečević, Mira
AU  - Krmar, Jovana
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2905
AB  - 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 percentage 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.
PB  - Oxford Univ Press Inc, Cary
T2  - Journal of Chromatographic Science
T1  - Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide
VL  - 55
IS  - 6
SP  - 625
EP  - 637
DO  - 10.1093/chromsci/bmx018
ER  - 
@article{
author = "Sljivić, Jasmina and Protić, Ana and Otašević, Biljana and Golubović, Jelena and Zečević, Mira and Krmar, Jovana",
year = "2017",
abstract = "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 percentage 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.",
publisher = "Oxford Univ Press Inc, Cary",
journal = "Journal of Chromatographic Science",
title = "Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide",
volume = "55",
number = "6",
pages = "625-637",
doi = "10.1093/chromsci/bmx018"
}
Sljivić, J., Protić, A., Otašević, B., Golubović, J., Zečević, M.,& Krmar, J.. (2017). Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide. in Journal of Chromatographic Science
Oxford Univ Press Inc, Cary., 55(6), 625-637.
https://doi.org/10.1093/chromsci/bmx018
Sljivić J, Protić A, Otašević B, Golubović J, Zečević M, Krmar J. Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide. in Journal of Chromatographic Science. 2017;55(6):625-637.
doi:10.1093/chromsci/bmx018 .
Sljivić, Jasmina, Protić, Ana, Otašević, Biljana, Golubović, Jelena, Zečević, Mira, Krmar, Jovana, "Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide" in Journal of Chromatographic Science, 55, no. 6 (2017):625-637,
https://doi.org/10.1093/chromsci/bmx018 . .

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