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New enantioselective LC method development and validation for the assay of modafinil.
J Pharm Biomed Anal. 2017 May 10; 138:267-271.JP

Abstract

For the first time, a new, fast and sensitive chromatographic method for the separation and determination of modafinil enantiomers was developed on chiral stationary phase with macrocyclic glycopeptide teicoplanin in the polar organic mode. The effect of the mobile phase composition and column temperature on the retention and enantioseparation were studied. The separation was performed using a Chirobiotic T column (250×4.6mm, 5μm) with methanol and triethylamine (100/0.05, v/v) as the mobile phase at a flow rate of 1.0mL/min, and UV detection at 225nm. The total analysis time is less than 6min, which is faster than the previous chiral HPLC methods (total run time of 12min). Calibration curves were linear (R2>0.999) over a concentration range 5-150μg/mL for each modafinil enantiomer. Limit of detection (LOD) and limit of quantification (LOQ) for (R)-modafinil were 15 and 45ng/mL and for (S)-modafinil were 20 and 60ng/mL, respectively. The recoveries were in the range of 100.5-102.3% with the relative standard deviations ranging from 0.4% to 1.0% for both enantiomers. It was demonstrated that the developed method was selective, precise and robust. The validated method was successfully applied for the separation and determination of modafinil enantiomers in the real samples.

Authors+Show Affiliations

Department of Analytical Chemistry, Faculty of Science, P.J. Šafárik University, Moyzesova 11, 040 01 Košice, Slovak Republic. Electronic address: mariannahrvn@gmail.com.Department of Analytical Chemistry, Faculty of Science, P.J. Šafárik University, Moyzesova 11, 040 01 Košice, Slovak Republic.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28231529

Citation

Harvanová, Marianna, and Taťána Gondová. "New Enantioselective LC Method Development and Validation for the Assay of Modafinil." Journal of Pharmaceutical and Biomedical Analysis, vol. 138, 2017, pp. 267-271.
Harvanová M, Gondová T. New enantioselective LC method development and validation for the assay of modafinil. J Pharm Biomed Anal. 2017;138:267-271.
Harvanová, M., & Gondová, T. (2017). New enantioselective LC method development and validation for the assay of modafinil. Journal of Pharmaceutical and Biomedical Analysis, 138, 267-271. https://doi.org/10.1016/j.jpba.2017.02.028
Harvanová M, Gondová T. New Enantioselective LC Method Development and Validation for the Assay of Modafinil. J Pharm Biomed Anal. 2017 May 10;138:267-271. PubMed PMID: 28231529.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - New enantioselective LC method development and validation for the assay of modafinil. AU - Harvanová,Marianna, AU - Gondová,Taťána, Y1 - 2017/02/16/ PY - 2016/12/14/received PY - 2017/02/06/revised PY - 2017/02/14/accepted PY - 2017/2/24/pubmed PY - 2017/6/29/medline PY - 2017/2/24/entrez KW - Chiral separation KW - HPLC KW - Modafinil KW - Pharmaceutical analysis KW - Teicoplanin SP - 267 EP - 271 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 138 N2 - For the first time, a new, fast and sensitive chromatographic method for the separation and determination of modafinil enantiomers was developed on chiral stationary phase with macrocyclic glycopeptide teicoplanin in the polar organic mode. The effect of the mobile phase composition and column temperature on the retention and enantioseparation were studied. The separation was performed using a Chirobiotic T column (250×4.6mm, 5μm) with methanol and triethylamine (100/0.05, v/v) as the mobile phase at a flow rate of 1.0mL/min, and UV detection at 225nm. The total analysis time is less than 6min, which is faster than the previous chiral HPLC methods (total run time of 12min). Calibration curves were linear (R2>0.999) over a concentration range 5-150μg/mL for each modafinil enantiomer. Limit of detection (LOD) and limit of quantification (LOQ) for (R)-modafinil were 15 and 45ng/mL and for (S)-modafinil were 20 and 60ng/mL, respectively. The recoveries were in the range of 100.5-102.3% with the relative standard deviations ranging from 0.4% to 1.0% for both enantiomers. It was demonstrated that the developed method was selective, precise and robust. The validated method was successfully applied for the separation and determination of modafinil enantiomers in the real samples. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/28231529/New_enantioselective_LC_method_development_and_validation_for_the_assay_of_modafinil_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(16)31390-5 DB - PRIME DP - Unbound Medicine ER -