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Enantioselective HPLC-DAD method for the determination of etodolac enantiomers in tablets, human plasma and application to comparative pharmacokinetic study of both enantiomers after a single oral dose to twelve healthy volunteers.
Talanta. 2014 Dec; 130:506-17.T

Abstract

An enantioselective high performance liquid chromatographic method with diode array detection (HPLC-DAD) was developed and validated for the determination of etodolac enantiomers in tablets and human plasma. Enantiomeric separation was achieved on a Kromasil Cellucoat chiral column (250 mm × 4.6mm i.d., 5 µm particle size) using a mobile phase consisting of hexane: isopropanol: triflouroacetic acid (90:10:0.1 v/v/v) at a flow rate of 1.0 mL min(-1). The chromatographic system enables the separation of the two enantiomers and the internal standard within a cycle time of 8 min. The resolution between the two enantiomers was 4.25 and the resolution between each enantiomer and the internal standard was more than 2.0. Detection was carried out at 274 nm, and the purity assessment was performed using a photodiode array detector. Solid phase extraction technique using C-18 cartridge was applied to extract the analytes from the plasma samples, and the percentage recovery was more than 95% for the lower quantification limit. The method has been validated with respect to selectivity, linearity, accuracy and precision, robustness, limit of detection and limit of quantification. The validation acceptance criteria were met in all cases. The linearity range for the determination of each enantiomer in human plasma was 0.4-30.0 µg mL(-1) and the limits of quantification of R-etodolac and S-etodolac were 0.20 and 0.19 µg mL(-1), respectively. The validated method was successfully applied to the determination of etodolac enantiomers in tablets and to a comparative pharmacokinetic study of the two enantiomers after the administration of 300 mg single oral dose etodolac racemate tablets to twelve healthy volunteers.

Authors+Show Affiliations

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Egypt. Electronic address: Ismailhewala@yahoo.com.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Egypt.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Damanhour, Egypt.Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Egypt.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

25159440

Citation

Hewala, Ismail I., et al. "Enantioselective HPLC-DAD Method for the Determination of Etodolac Enantiomers in Tablets, Human Plasma and Application to Comparative Pharmacokinetic Study of Both Enantiomers After a Single Oral Dose to Twelve Healthy Volunteers." Talanta, vol. 130, 2014, pp. 506-17.
Hewala II, Moneeb MS, Elmongy HA, et al. Enantioselective HPLC-DAD method for the determination of etodolac enantiomers in tablets, human plasma and application to comparative pharmacokinetic study of both enantiomers after a single oral dose to twelve healthy volunteers. Talanta. 2014;130:506-17.
Hewala, I. I., Moneeb, M. S., Elmongy, H. A., & Wahbi, A. A. (2014). Enantioselective HPLC-DAD method for the determination of etodolac enantiomers in tablets, human plasma and application to comparative pharmacokinetic study of both enantiomers after a single oral dose to twelve healthy volunteers. Talanta, 130, 506-17. https://doi.org/10.1016/j.talanta.2014.07.011
Hewala II, et al. Enantioselective HPLC-DAD Method for the Determination of Etodolac Enantiomers in Tablets, Human Plasma and Application to Comparative Pharmacokinetic Study of Both Enantiomers After a Single Oral Dose to Twelve Healthy Volunteers. Talanta. 2014;130:506-17. PubMed PMID: 25159440.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enantioselective HPLC-DAD method for the determination of etodolac enantiomers in tablets, human plasma and application to comparative pharmacokinetic study of both enantiomers after a single oral dose to twelve healthy volunteers. AU - Hewala,Ismail I, AU - Moneeb,Marwa S, AU - Elmongy,Hatem A, AU - Wahbi,Abdel-Aziz M, Y1 - 2014/07/11/ PY - 2014/03/02/received PY - 2014/06/02/revised PY - 2014/07/06/accepted PY - 2014/8/28/entrez PY - 2014/8/28/pubmed PY - 2015/5/13/medline KW - Enantioselective HPLC-DAD KW - Etodolac enantiomers KW - Pharmacokinetics KW - Solid phase extraction SP - 506 EP - 17 JF - Talanta JO - Talanta VL - 130 N2 - An enantioselective high performance liquid chromatographic method with diode array detection (HPLC-DAD) was developed and validated for the determination of etodolac enantiomers in tablets and human plasma. Enantiomeric separation was achieved on a Kromasil Cellucoat chiral column (250 mm × 4.6mm i.d., 5 µm particle size) using a mobile phase consisting of hexane: isopropanol: triflouroacetic acid (90:10:0.1 v/v/v) at a flow rate of 1.0 mL min(-1). The chromatographic system enables the separation of the two enantiomers and the internal standard within a cycle time of 8 min. The resolution between the two enantiomers was 4.25 and the resolution between each enantiomer and the internal standard was more than 2.0. Detection was carried out at 274 nm, and the purity assessment was performed using a photodiode array detector. Solid phase extraction technique using C-18 cartridge was applied to extract the analytes from the plasma samples, and the percentage recovery was more than 95% for the lower quantification limit. The method has been validated with respect to selectivity, linearity, accuracy and precision, robustness, limit of detection and limit of quantification. The validation acceptance criteria were met in all cases. The linearity range for the determination of each enantiomer in human plasma was 0.4-30.0 µg mL(-1) and the limits of quantification of R-etodolac and S-etodolac were 0.20 and 0.19 µg mL(-1), respectively. The validated method was successfully applied to the determination of etodolac enantiomers in tablets and to a comparative pharmacokinetic study of the two enantiomers after the administration of 300 mg single oral dose etodolac racemate tablets to twelve healthy volunteers. SN - 1873-3573 UR - https://www.unboundmedicine.com/medline/citation/25159440/Enantioselective_HPLC_DAD_method_for_the_determination_of_etodolac_enantiomers_in_tablets_human_plasma_and_application_to_comparative_pharmacokinetic_study_of_both_enantiomers_after_a_single_oral_dose_to_twelve_healthy_volunteers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0039-9140(14)00564-5 DB - PRIME DP - Unbound Medicine ER -