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Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]

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2016
2660.pdf (215.8Kb)
Authors
Maksić, Jelena
Tumpa, Anja
Popović, Igor
Jančić-Stojanović, Biljana
Article (Published version)
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Abstract
The purpose of the present research was to conduct stress degradation studies on the olopatadine hydrochloride, an antiallergic drug, using the hydrophilic interaction liquid chromatography (HILIC). HILIC requires the utilization of polar and moderately polar stationary phases and aqueous-organic mobile phase usually containing more than 70% of organic solvent. In this study, olopatadine hydrochloride was subjected to acid and base hydrolysis, oxidation and thermolytic degradation in order to estimate its stability under different stress conditions recommended by ICHQ1A (R2) guideline. Degree of degradation was followed by HILIC method. The chromatographic conditions were: column Betasil Cyano (100 mmx4.6 mm, 5 mu m particle size), mobile phase consisted of acetonitrile and ammonium acetate 5 mM (pH adjusted to 4.50) in ratio 85: 15 V/V, flow rate was 1 mL min(-1), column temperature was set at 30 degrees C and detection was performed at 257 nm. Results obtained for stress studies indi...cated that olopatadine hydrochloride underwent transformation under acidic and oxidative (30% hydrogen peroxyde) conditions showing high degree of degradation. Furthermore, it was found that olopatadine hydrochloride is relatively stable when exposed to thermal (60 degrees C) and basic (1 M NaOH) conditions. Therewith, kinetics of degradation reaction was determined with an aim to define the corresponding reaction rate constants and half-lives. Firstly, the order of the reaction was evaluated experimentally using the integral method. Based on the calculated values of the correlation coefficients, it was shown that the acidic, basic and oxidative degradation are the second-order reaction. High stability under basic conditions was achieved on the basis of the great degradation half-life values. Also, it has been verified that acidic degradation is the fastest reaction.

Source:
Hemijska industrija, 2016, 70, 3, 339-346
Publisher:
  • Savez hemijskih inženjera, Beograd
Projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.2298/HEMIND150404039M

ISSN: 0367-598X

WoS: 000380756800011

Scopus: 2-s2.0-84978971795
[ Google Scholar ]
URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2662
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy
TY  - JOUR
AU  - Maksić, Jelena
AU  - Tumpa, Anja
AU  - Popović, Igor
AU  - Jančić-Stojanović, Biljana
PY  - 2016
UR  - http://farfar.pharmacy.bg.ac.rs/handle/123456789/2662
AB  - The purpose of the present research was to conduct stress degradation studies on the olopatadine hydrochloride, an antiallergic drug, using the hydrophilic interaction liquid chromatography (HILIC). HILIC requires the utilization of polar and moderately polar stationary phases and aqueous-organic mobile phase usually containing more than 70% of organic solvent. In this study, olopatadine hydrochloride was subjected to acid and base hydrolysis, oxidation and thermolytic degradation in order to estimate its stability under different stress conditions recommended by ICHQ1A (R2) guideline. Degree of degradation was followed by HILIC method. The chromatographic conditions were: column Betasil Cyano (100 mmx4.6 mm, 5 mu m particle size), mobile phase consisted of acetonitrile and ammonium acetate 5 mM (pH adjusted to 4.50) in ratio 85: 15 V/V, flow rate was 1 mL min(-1), column temperature was set at 30 degrees C and detection was performed at 257 nm. Results obtained for stress studies indicated that olopatadine hydrochloride underwent transformation under acidic and oxidative (30% hydrogen peroxyde) conditions showing high degree of degradation. Furthermore, it was found that olopatadine hydrochloride is relatively stable when exposed to thermal (60 degrees C) and basic (1 M NaOH) conditions. Therewith, kinetics of degradation reaction was determined with an aim to define the corresponding reaction rate constants and half-lives. Firstly, the order of the reaction was evaluated experimentally using the integral method. Based on the calculated values of the correlation coefficients, it was shown that the acidic, basic and oxidative degradation are the second-order reaction. High stability under basic conditions was achieved on the basis of the great degradation half-life values. Also, it has been verified that acidic degradation is the fastest reaction.
PB  - Savez hemijskih inženjera, Beograd
T2  - Hemijska industrija
T1  - Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]
VL  - 70
IS  - 3
SP  - 339
EP  - 346
DO  - 10.2298/HEMIND150404039M
ER  - 
@article{
author = "Maksić, Jelena and Tumpa, Anja and Popović, Igor and Jančić-Stojanović, Biljana",
year = "2016",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/2662",
abstract = "The purpose of the present research was to conduct stress degradation studies on the olopatadine hydrochloride, an antiallergic drug, using the hydrophilic interaction liquid chromatography (HILIC). HILIC requires the utilization of polar and moderately polar stationary phases and aqueous-organic mobile phase usually containing more than 70% of organic solvent. In this study, olopatadine hydrochloride was subjected to acid and base hydrolysis, oxidation and thermolytic degradation in order to estimate its stability under different stress conditions recommended by ICHQ1A (R2) guideline. Degree of degradation was followed by HILIC method. The chromatographic conditions were: column Betasil Cyano (100 mmx4.6 mm, 5 mu m particle size), mobile phase consisted of acetonitrile and ammonium acetate 5 mM (pH adjusted to 4.50) in ratio 85: 15 V/V, flow rate was 1 mL min(-1), column temperature was set at 30 degrees C and detection was performed at 257 nm. Results obtained for stress studies indicated that olopatadine hydrochloride underwent transformation under acidic and oxidative (30% hydrogen peroxyde) conditions showing high degree of degradation. Furthermore, it was found that olopatadine hydrochloride is relatively stable when exposed to thermal (60 degrees C) and basic (1 M NaOH) conditions. Therewith, kinetics of degradation reaction was determined with an aim to define the corresponding reaction rate constants and half-lives. Firstly, the order of the reaction was evaluated experimentally using the integral method. Based on the calculated values of the correlation coefficients, it was shown that the acidic, basic and oxidative degradation are the second-order reaction. High stability under basic conditions was achieved on the basis of the great degradation half-life values. Also, it has been verified that acidic degradation is the fastest reaction.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Hemijska industrija",
title = "Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]",
volume = "70",
number = "3",
pages = "339-346",
doi = "10.2298/HEMIND150404039M"
}
Maksić J, Tumpa A, Popović I, Jančić-Stojanović B. Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]. Hemijska industrija. 2016;70(3):339-346
Maksić, J., Tumpa, A., Popović, I.,& Jančić-Stojanović, B. (2016). Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija].
Hemijska industrijaSavez hemijskih inženjera, Beograd., 70(3), 339-346.
https://doi.org/10.2298/HEMIND150404039M
Maksić Jelena, Tumpa Anja, Popović Igor, Jančić-Stojanović Biljana, "Investigation of olopatadine hydrochloride under stress conditions by hydrophilic interaction liquid chromatography [Ispitivanje olopatadin-hidrohlorida pod stres uslovima metodom tečne hromatografije hidrofilnih interakcija]" 70, no. 3 (2016):339-346,
https://doi.org/10.2298/HEMIND150404039M .

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