Experimental design optimization of simultaneous enantiomeric separation of atenolol and chlorthalidone binary mixture by high-performance liquid chromatography using polysaccharide-based stationary phases
© 2021 Wiley Periodicals LLC..
In this work, enantiomeric separation of a drug combination of two chiral drugs, namely, atenolol and chlorthalidone, is described. Prior investigation of the effect of different variables on the resolution of the enantiomers' peaks and the total run time represented by the retention time of the last eluted peak was conducted using face-centered composite design. Twenty-two experiments were carried out by varying the chiral stationary phase type as a categorical factor and mobile phase composition including the percentage of ethanol and percentage of diethylamine as continuous factors. According to the optimization process, a mobile phase consisting of hexane:ethanol:DEA:TFA (60:40:0.2:0.1%, v/v/v/v) pumped at flow rate 1 ml min-1 onto Lux-Cellulose 2 stationary phase was applied for the chiral separation and quantification of the drug combination at 230 nm. Application of the developed method to the pharmaceutical formulation of this combination was successfully performed, and satisfactory percentage of recoveries was obtained. The method was also fully validated following International Conference on Harmonization (ICH) guidelines. This method could be of high value and relevance for application in quality control laboratories.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
Chirality - 33(2021), 7 vom: 08. Juli, Seite 397-408 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hassan, Rasha M [VerfasserIn] |
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| Links: |
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| Themen: |
50VV3VW0TI |
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| Anmerkungen: |
Date Completed 24.11.2021 Date Revised 24.11.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/chir.23315 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM325157057 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2021 Wiley Periodicals LLC. | ||
| 520 | |a In this work, enantiomeric separation of a drug combination of two chiral drugs, namely, atenolol and chlorthalidone, is described. Prior investigation of the effect of different variables on the resolution of the enantiomers' peaks and the total run time represented by the retention time of the last eluted peak was conducted using face-centered composite design. Twenty-two experiments were carried out by varying the chiral stationary phase type as a categorical factor and mobile phase composition including the percentage of ethanol and percentage of diethylamine as continuous factors. According to the optimization process, a mobile phase consisting of hexane:ethanol:DEA:TFA (60:40:0.2:0.1%, v/v/v/v) pumped at flow rate 1 ml min-1 onto Lux-Cellulose 2 stationary phase was applied for the chiral separation and quantification of the drug combination at 230 nm. Application of the developed method to the pharmaceutical formulation of this combination was successfully performed, and satisfactory percentage of recoveries was obtained. The method was also fully validated following International Conference on Harmonization (ICH) guidelines. This method could be of high value and relevance for application in quality control laboratories | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HPLC | |
| 650 | 4 | |a antihypertensive mixture | |
| 650 | 4 | |a chiral stationary phases | |
| 650 | 4 | |a design of experiment | |
| 650 | 4 | |a enantiomeric separation | |
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| 650 | 7 | |a Chlorthalidone |2 NLM | |
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| 700 | 1 | |a El-Azzouny, Aida A |e verfasserin |4 aut | |
| 700 | 1 | |a Aboul-Enein, Hassan Y |e verfasserin |4 aut | |
| 700 | 1 | |a Fouad, Marwa A |e verfasserin |4 aut | |
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