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Enantioselective separation of eight antihistamines with α1-acid glycoprotein-based chiral stationary phase by HPLC: Development and validation for the enantiomeric quality control.
J Pharm Biomed Anal 2019; 176:112803JP

Abstract

In the present paper, a sensitive and selective chiral LC method has been developed for enantiomeric separation and determination of eight antihistamines in pharmaceutical formulations. Enantiomeric separation was achieved on the α1-acid glycoprotein-based chiral stationary phase known as Chiralpak AGP. The effects of the mobile phase composition, type and proportion of organic modifier and the concentration and pH of the buffer on retention and resolution were fully investigated. All enantiomers of target analytes were successfully separated with the mobile phase consisting of methanol and 10 mM ammonium acetate buffer, at a flow rate of 0.9 mL min-1. Calibration curve of each enantiomer was linear over the concentration range of 5.0-100 μg mL-1, with the correlation coefficient above 0.9990. The limits of detection and quantification were below 0.80 and 3.18 μg mL-1, respectively. The recoveries were in the range of 98.0-102.4% with the relative standard deviation lower than 2.88% for all enantiomers. The validated method was demonstrated to be suitable for the quality control of the enantiomeric composition of antihistamines present in pharmaceuticals. Finally, the proposed chiral LC method was applied to the determination of antihistamines enantiomers in commercially available tablets containing racemic mixtures of compounds. Quantitative results of the commercial tablets demonstrated that the difference between the declared and determined values did not exceed 1.45%, and chiral antihistamines drugs were present in the form of racemates.

Authors+Show Affiliations

School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road Shenhe District, 110016 Shenyang, Liaoning Province, PR China.School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road Shenhe District, 110016 Shenyang, Liaoning Province, PR China.School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road Shenhe District, 110016 Shenyang, Liaoning Province, PR China.School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road Shenhe District, 110016 Shenyang, Liaoning Province, PR China. Electronic address: lqyxm@hotmail.com.School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road Shenhe District, 110016 Shenyang, Liaoning Province, PR China. Electronic address: syykdx410@163.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31442761

Citation

Zhu, Bolin, et al. "Enantioselective Separation of Eight Antihistamines With Α1-acid Glycoprotein-based Chiral Stationary Phase By HPLC: Development and Validation for the Enantiomeric Quality Control." Journal of Pharmaceutical and Biomedical Analysis, vol. 176, 2019, p. 112803.
Zhu B, Xue M, Liu B, et al. Enantioselective separation of eight antihistamines with α1-acid glycoprotein-based chiral stationary phase by HPLC: Development and validation for the enantiomeric quality control. J Pharm Biomed Anal. 2019;176:112803.
Zhu, B., Xue, M., Liu, B., Li, Q., & Guo, X. (2019). Enantioselective separation of eight antihistamines with α1-acid glycoprotein-based chiral stationary phase by HPLC: Development and validation for the enantiomeric quality control. Journal of Pharmaceutical and Biomedical Analysis, 176, p. 112803. doi:10.1016/j.jpba.2019.112803.
Zhu B, et al. Enantioselective Separation of Eight Antihistamines With Α1-acid Glycoprotein-based Chiral Stationary Phase By HPLC: Development and Validation for the Enantiomeric Quality Control. J Pharm Biomed Anal. 2019 Aug 10;176:112803. PubMed PMID: 31442761.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enantioselective separation of eight antihistamines with α1-acid glycoprotein-based chiral stationary phase by HPLC: Development and validation for the enantiomeric quality control. AU - Zhu,Bolin, AU - Xue,Mengyao, AU - Liu,Beibei, AU - Li,Qing, AU - Guo,Xingjie, Y1 - 2019/08/10/ PY - 2019/06/24/received PY - 2019/08/01/revised PY - 2019/08/02/accepted PY - 2019/8/24/pubmed PY - 2019/8/24/medline PY - 2019/8/24/entrez KW - Antihistamines enantiomers KW - Chiral separation KW - Enantioselective determination KW - HPLC KW - α(1)-Acid glycoprotein-based chiral stationary phase SP - 112803 EP - 112803 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 176 N2 - In the present paper, a sensitive and selective chiral LC method has been developed for enantiomeric separation and determination of eight antihistamines in pharmaceutical formulations. Enantiomeric separation was achieved on the α1-acid glycoprotein-based chiral stationary phase known as Chiralpak AGP. The effects of the mobile phase composition, type and proportion of organic modifier and the concentration and pH of the buffer on retention and resolution were fully investigated. All enantiomers of target analytes were successfully separated with the mobile phase consisting of methanol and 10 mM ammonium acetate buffer, at a flow rate of 0.9 mL min-1. Calibration curve of each enantiomer was linear over the concentration range of 5.0-100 μg mL-1, with the correlation coefficient above 0.9990. The limits of detection and quantification were below 0.80 and 3.18 μg mL-1, respectively. The recoveries were in the range of 98.0-102.4% with the relative standard deviation lower than 2.88% for all enantiomers. The validated method was demonstrated to be suitable for the quality control of the enantiomeric composition of antihistamines present in pharmaceuticals. Finally, the proposed chiral LC method was applied to the determination of antihistamines enantiomers in commercially available tablets containing racemic mixtures of compounds. Quantitative results of the commercial tablets demonstrated that the difference between the declared and determined values did not exceed 1.45%, and chiral antihistamines drugs were present in the form of racemates. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/31442761/Enantioselective_separation_of_eight_antihistamines_with_α1-acid_glycoprotein-based_chiral_stationary_phase_by_HPLC:_Development_and_validation_for_the_enantiomeric_quality_control L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(19)31554-7 DB - PRIME DP - Unbound Medicine ER -