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Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method

Kinetika degradacije i karakterizacija degradacionih proizvoda losartan kalijuma lcms/ms metodom

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Degradation_Kinetics_and_pub_2019.pdf (451.8Kb)
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Dobričić, Vladimir
Marković, Bojan
Article (Published version)
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Abstract
U ovom radu opisano je ispitivanje stabilnosti losartan kalijuma primenom tečne hromatografije sa UV i MS-MS detekcijom i prikazan je njegov profil degradacionih proizvoda. Rastvor losartan kalijuma bio je izložen dejstvu sledećih stres agenasa: 0,1 M HCl; 0,1 M NaOH i 3% (v/v) H2O2. Rastvori losartan kalijuma analizirani su gradijentnim eluiranjem sa acetonitrilom i 0,1% (v/v) vodenim rastvorom CF3COOH pri konstantnom protoku od 0,5 ml min-1 i vremenom trajanja od 22 min. Degradacija u rastvorima losartan kalijuma koji su 7 dana bili izloženi dejstvu 0,1 M HCl i 0,1 M NaOH bila je manja od 1%, dok je u prisustvu 3% (v/v) H2O2 bila značajno veća (oko 10%). Identifikacija i strukturna analiza glavnih degradacionih proizvoda losartan kalijuma izvršena je primenom LC-MS/MS metode. Grafička zavisnost izmerenih koncentracija u funkciji vremena ukazuje da se losartan kalijum u rastvoru 3% (v/v) H2O2 degradira ...kinetikom pseudo nultog reda sa konstantnom brzine reakcije od 1.48ꞏ10-8 mol L-1 dan-1.

This paper presents study of losartan potassium stability evaluation by liquid chromatography with UV/VIS and MS-MS detection and its degradation profile. A solution of losartan potassium was exposed to the following stress agents: 0.1 M HCl, 0.1 M NaOH, and 3% (v/v) H2O2. The analyses of losartan potassium solutions were carried out in a gradient elution mode with acetonitrile and 0.1% (v/v) CF3COOH aqueous solution and constant flow rate of 0.5 mL min-1 within 22 min run time. After 7 days of losartan potassium solutions exposure to the stress agents at room temperature, it was found that the degree of degradation in the presence of 0.1 M HCl and 0.1 M NaOH was less than 1%, while in the presence of 3% H2O2 degradation was significantly higher (about 10%). Chemical structure elucidation of the major degradation products of losartan potassium was performed using LC-MS/MS method. The concentration versus time plot indicated that in 3% (v/v) H2O2 solution losartan potassium was degraded... according to the pseudo zero-order reaction kinetics with 1.4810-8 mol L-1 day-1 rate constant. © 2019, Pharmaceutical Association of Serbia. All rights reserved.

Keywords:
Forced degradation / Kinetics / LC-MS/MS / Losartan potassium / Losartan kalijum / Forsirana degradacija / Kinetika / LC-MS/MS
Source:
Arhiv za farmaciju, 2019, 69, 2, 80-89
Publisher:
  • Pharmaceutical Association of Serbia
Funding / projects:
  • Development of molecules with antiinflammatory and cardioprotective activity: structural modifications, modelling, physicochemical characterization and formulation investigations (RS-172041)
  • Development of micro- and nanosystems as carriers for drugs with anti-inflammatory effect and methods for their characterization (RS-34031)

DOI: 10.5937/arhfarm1902080X

ISSN: 0004-1963

Scopus: 2-s2.0-85090640124
[ Google Scholar ]
2
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3665
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Dobričić, Vladimir
AU  - Marković, Bojan
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3665
AB  - U  ovom  radu  opisano  je  ispitivanje  stabilnosti  losartan  kalijuma  primenom  tečne hromatografije sa UV i MS-MS detekcijom i prikazan je njegov profil degradacionih proizvoda. Rastvor  losartan  kalijuma  bio  je  izložen  dejstvu  sledećih  stres  agenasa:  0,1  M  HCl;                       0,1 M NaOH i 3% (v/v) H2O2. Rastvori losartan kalijuma analizirani su gradijentnim eluiranjem sa  acetonitrilom  i  0,1%  (v/v)  vodenim  rastvorom  CF3COOH  pri  konstantnom protoku  od    0,5 ml min-1 i vremenom trajanja od 22 min. Degradacija u rastvorima losartan kalijuma koji su 7 dana bili izloženi dejstvu 0,1 M HCl i 0,1 M NaOH bila je manja od 1%, dok je u prisustvu 3% (v/v) H2O2 bila značajno veća (oko 10%).  Identifikacija  i  strukturna  analiza  glavnih  degradacionih  proizvoda  losartan  kalijuma izvršena je primenom LC-MS/MS metode. Grafička  zavisnost  izmerenih  koncentracija  u  funkciji  vremena  ukazuje  da  se  losartan kalijum  u  rastvoru  3%  (v/v)  H2O2  degradira  kinetikom  pseudo nultog  reda  sa  konstantnom brzine reakcije od 1.48ꞏ10-8 mol L-1 dan-1.
AB  - This paper presents study of losartan potassium stability evaluation by liquid chromatography with UV/VIS and MS-MS detection and its degradation profile. A solution of losartan potassium was exposed to the following stress agents: 0.1 M HCl, 0.1 M NaOH, and 3% (v/v) H2O2. The analyses of losartan potassium solutions were carried out in a gradient elution mode with acetonitrile and 0.1% (v/v) CF3COOH aqueous solution and constant flow rate of 0.5 mL min-1 within 22 min run time. After 7 days of losartan potassium solutions exposure to the stress agents at room temperature, it was found that the degree of degradation in the presence of 0.1 M HCl and 0.1 M NaOH was less than 1%, while in the presence of 3% H2O2 degradation was significantly higher (about 10%). Chemical structure elucidation of the major degradation products of losartan potassium was performed using LC-MS/MS method. The concentration versus time plot indicated that in 3% (v/v) H2O2 solution losartan potassium was degraded according to the pseudo zero-order reaction kinetics with 1.4810-8 mol L-1 day-1 rate constant. © 2019, Pharmaceutical Association of Serbia. All rights reserved.
PB  - Pharmaceutical Association of Serbia
T2  - Arhiv za farmaciju
T1  - Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method
T1  - Kinetika degradacije i karakterizacija degradacionih proizvoda losartan kalijuma lcms/ms metodom
VL  - 69
IS  - 2
SP  - 80
EP  - 89
DO  - 10.5937/arhfarm1902080X
ER  - 
@article{
author = "Dobričić, Vladimir and Marković, Bojan",
year = "2019",
abstract = "U  ovom  radu  opisano  je  ispitivanje  stabilnosti  losartan  kalijuma  primenom  tečne hromatografije sa UV i MS-MS detekcijom i prikazan je njegov profil degradacionih proizvoda. Rastvor  losartan  kalijuma  bio  je  izložen  dejstvu  sledećih  stres  agenasa:  0,1  M  HCl;                       0,1 M NaOH i 3% (v/v) H2O2. Rastvori losartan kalijuma analizirani su gradijentnim eluiranjem sa  acetonitrilom  i  0,1%  (v/v)  vodenim  rastvorom  CF3COOH  pri  konstantnom protoku  od    0,5 ml min-1 i vremenom trajanja od 22 min. Degradacija u rastvorima losartan kalijuma koji su 7 dana bili izloženi dejstvu 0,1 M HCl i 0,1 M NaOH bila je manja od 1%, dok je u prisustvu 3% (v/v) H2O2 bila značajno veća (oko 10%).  Identifikacija  i  strukturna  analiza  glavnih  degradacionih  proizvoda  losartan  kalijuma izvršena je primenom LC-MS/MS metode. Grafička  zavisnost  izmerenih  koncentracija  u  funkciji  vremena  ukazuje  da  se  losartan kalijum  u  rastvoru  3%  (v/v)  H2O2  degradira  kinetikom  pseudo nultog  reda  sa  konstantnom brzine reakcije od 1.48ꞏ10-8 mol L-1 dan-1., This paper presents study of losartan potassium stability evaluation by liquid chromatography with UV/VIS and MS-MS detection and its degradation profile. A solution of losartan potassium was exposed to the following stress agents: 0.1 M HCl, 0.1 M NaOH, and 3% (v/v) H2O2. The analyses of losartan potassium solutions were carried out in a gradient elution mode with acetonitrile and 0.1% (v/v) CF3COOH aqueous solution and constant flow rate of 0.5 mL min-1 within 22 min run time. After 7 days of losartan potassium solutions exposure to the stress agents at room temperature, it was found that the degree of degradation in the presence of 0.1 M HCl and 0.1 M NaOH was less than 1%, while in the presence of 3% H2O2 degradation was significantly higher (about 10%). Chemical structure elucidation of the major degradation products of losartan potassium was performed using LC-MS/MS method. The concentration versus time plot indicated that in 3% (v/v) H2O2 solution losartan potassium was degraded according to the pseudo zero-order reaction kinetics with 1.4810-8 mol L-1 day-1 rate constant. © 2019, Pharmaceutical Association of Serbia. All rights reserved.",
publisher = "Pharmaceutical Association of Serbia",
journal = "Arhiv za farmaciju",
title = "Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method, Kinetika degradacije i karakterizacija degradacionih proizvoda losartan kalijuma lcms/ms metodom",
volume = "69",
number = "2",
pages = "80-89",
doi = "10.5937/arhfarm1902080X"
}
Dobričić, V.,& Marković, B.. (2019). Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method. in Arhiv za farmaciju
Pharmaceutical Association of Serbia., 69(2), 80-89.
https://doi.org/10.5937/arhfarm1902080X
Dobričić V, Marković B. Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method. in Arhiv za farmaciju. 2019;69(2):80-89.
doi:10.5937/arhfarm1902080X .
Dobričić, Vladimir, Marković, Bojan, "Degradation kinetics and characterization of degradation products of losartan potassium by lc-ms/ms method" in Arhiv za farmaciju, 69, no. 2 (2019):80-89,
https://doi.org/10.5937/arhfarm1902080X . .

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