Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study

Priscila Aburachid Cardoso, Diego Beltrao Pereira, Mohammed Farrag El-behairy, Ashraf GHANEM, Gerson Antonio Pianetti, Isabela Costa Cesar

Research output: Contribution to journalArticle

Abstract

Chloroquine is a chiral antimalarial drug and demonstrates enantioselective pharmacodynamic and pharmacokinetic properties. However, this drug is administered as racemate. The knowledge of stereoselective aspects of these agents may be useful to better understand their mechanisms of action and to optimize their safety and/or clinical efficacy. In this study, an enantioselective analytical method for the quantification of chloroquine enantiomers was developed using HPLC-UV. The chromatographic conditions were: Chirobiotic V column (100 × 2.1 mm, 5 μm) at 25°C, mobile phase containing methanol:acetic acid:triethylamine (100:0.12:0.12), flow rate 1 mL/min, injection volume 10 μL and detection at 258 nm. The validation parameters evaluated were selectivity, linearity, precision, accuracy, and robustness. In addition, a stability study after forced degradation of chloroquine enantiomers was performed. The enantioseparation of chloroquine using a polysaccharide-based chiral stationary phase (Chiralpak ID) at different mobile phase composition was evaluated and the chromatographic performance of both columns was compared. Thus, a stability-indicating chiral analytical method was developed and fully validated, allowing the separation of chloroquine enantiomers and its degradation products in tablets available in Brazil.
LanguageEnglish
Pages1-8
Number of pages8
JournalJournal of Chromatographic Science
DOIs
Publication statusE-pub ahead of print - 23 Feb 2019

Fingerprint

Validation Studies
Chloroquine
Enantiomers
Pharmacodynamics
Degradation
Pharmacokinetics
Antimalarials
Phase composition
Acetic Acid
Tablets
Polysaccharides
Brazil
Methanol
High Pressure Liquid Chromatography
Flow rate
Safety
Injections
Pharmaceutical Preparations

Cite this

Aburachid Cardoso, Priscila ; Beltrao Pereira, Diego ; Farrag El-behairy, Mohammed ; GHANEM, Ashraf ; Pianetti, Gerson Antonio ; Costa Cesar, Isabela. / Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study. In: Journal of Chromatographic Science. 2019 ; pp. 1-8.
@article{01de3efa7ef646cd8f6f8cad59c44fd7,
title = "Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study",
abstract = "Chloroquine is a chiral antimalarial drug and demonstrates enantioselective pharmacodynamic and pharmacokinetic properties. However, this drug is administered as racemate. The knowledge of stereoselective aspects of these agents may be useful to better understand their mechanisms of action and to optimize their safety and/or clinical efficacy. In this study, an enantioselective analytical method for the quantification of chloroquine enantiomers was developed using HPLC-UV. The chromatographic conditions were: Chirobiotic V column (100 × 2.1 mm, 5 μm) at 25°C, mobile phase containing methanol:acetic acid:triethylamine (100:0.12:0.12), flow rate 1 mL/min, injection volume 10 μL and detection at 258 nm. The validation parameters evaluated were selectivity, linearity, precision, accuracy, and robustness. In addition, a stability study after forced degradation of chloroquine enantiomers was performed. The enantioseparation of chloroquine using a polysaccharide-based chiral stationary phase (Chiralpak ID) at different mobile phase composition was evaluated and the chromatographic performance of both columns was compared. Thus, a stability-indicating chiral analytical method was developed and fully validated, allowing the separation of chloroquine enantiomers and its degradation products in tablets available in Brazil.",
keywords = "Enantioselective Chromatographic Separation, Chloroquine",
author = "{Aburachid Cardoso}, Priscila and {Beltrao Pereira}, Diego and {Farrag El-behairy}, Mohammed and Ashraf GHANEM and Pianetti, {Gerson Antonio} and {Costa Cesar}, Isabela",
year = "2019",
month = "2",
day = "23",
doi = "10.1093/chromsci/bmz014",
language = "English",
pages = "1--8",
journal = "Journal of Chromatographic Science",
issn = "0021-9665",
publisher = "Preston Publications",

}

Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study. / Aburachid Cardoso, Priscila ; Beltrao Pereira, Diego; Farrag El-behairy, Mohammed; GHANEM, Ashraf; Pianetti, Gerson Antonio; Costa Cesar, Isabela.

In: Journal of Chromatographic Science, 23.02.2019, p. 1-8.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Chirobiotic V Versus Chiralpak ID for the Enantioselective Chromatographic Separation of Chloroquine: Stability and Validation Study

AU - Aburachid Cardoso, Priscila

AU - Beltrao Pereira, Diego

AU - Farrag El-behairy, Mohammed

AU - GHANEM, Ashraf

AU - Pianetti, Gerson Antonio

AU - Costa Cesar, Isabela

PY - 2019/2/23

Y1 - 2019/2/23

N2 - Chloroquine is a chiral antimalarial drug and demonstrates enantioselective pharmacodynamic and pharmacokinetic properties. However, this drug is administered as racemate. The knowledge of stereoselective aspects of these agents may be useful to better understand their mechanisms of action and to optimize their safety and/or clinical efficacy. In this study, an enantioselective analytical method for the quantification of chloroquine enantiomers was developed using HPLC-UV. The chromatographic conditions were: Chirobiotic V column (100 × 2.1 mm, 5 μm) at 25°C, mobile phase containing methanol:acetic acid:triethylamine (100:0.12:0.12), flow rate 1 mL/min, injection volume 10 μL and detection at 258 nm. The validation parameters evaluated were selectivity, linearity, precision, accuracy, and robustness. In addition, a stability study after forced degradation of chloroquine enantiomers was performed. The enantioseparation of chloroquine using a polysaccharide-based chiral stationary phase (Chiralpak ID) at different mobile phase composition was evaluated and the chromatographic performance of both columns was compared. Thus, a stability-indicating chiral analytical method was developed and fully validated, allowing the separation of chloroquine enantiomers and its degradation products in tablets available in Brazil.

AB - Chloroquine is a chiral antimalarial drug and demonstrates enantioselective pharmacodynamic and pharmacokinetic properties. However, this drug is administered as racemate. The knowledge of stereoselective aspects of these agents may be useful to better understand their mechanisms of action and to optimize their safety and/or clinical efficacy. In this study, an enantioselective analytical method for the quantification of chloroquine enantiomers was developed using HPLC-UV. The chromatographic conditions were: Chirobiotic V column (100 × 2.1 mm, 5 μm) at 25°C, mobile phase containing methanol:acetic acid:triethylamine (100:0.12:0.12), flow rate 1 mL/min, injection volume 10 μL and detection at 258 nm. The validation parameters evaluated were selectivity, linearity, precision, accuracy, and robustness. In addition, a stability study after forced degradation of chloroquine enantiomers was performed. The enantioseparation of chloroquine using a polysaccharide-based chiral stationary phase (Chiralpak ID) at different mobile phase composition was evaluated and the chromatographic performance of both columns was compared. Thus, a stability-indicating chiral analytical method was developed and fully validated, allowing the separation of chloroquine enantiomers and its degradation products in tablets available in Brazil.

KW - Enantioselective Chromatographic Separation

KW - Chloroquine

U2 - 10.1093/chromsci/bmz014

DO - 10.1093/chromsci/bmz014

M3 - Article

SP - 1

EP - 8

JO - Journal of Chromatographic Science

T2 - Journal of Chromatographic Science

JF - Journal of Chromatographic Science

SN - 0021-9665

ER -