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Rapid chiral separation and impurity determination of ropivacaine and bupivacaine by Densitometry-HPTLC, using mucopolysaccharide as chiral mobile phase additive
Nahla Nour El-Din Salama (1,*)
(1) Pharmaceutical Chemistry, Department National Organization for Drug Control and Research, Giza, 35521, Egypt
(*) Corresponding Author
Received: 02 Nov 2013 | Revised: 27 Nov 2013 | Accepted: 28 Nov 2013 | Published: 30 Jun 2014 | Issue Date: June 2014
Abstract
Enantio separation of the local anesthetic drugs; ropivacaine (Rop), bupivacaine (Bup) and potential organic impurities (2,6-Dimethylaniline, 2,6-DMA) were accomplished on HPTLC using mucopolysaccharide selector (Chondroitin) as chiral mobile phase additive (CMPA). The enantioseparation was achieved in acetonitrile:water:methanol (16:3:1, v:v:v) containing 0.25% chondroitin as chiral mobile phase additive. The influence of separation conditions, including type and concentration of chiral selector, organic modifiers and temperatures on enantioseparation were evaluated. The enantioselective HPTLC method was validated to control the enantiomeric purity of the (S)-enantiomers (S-Rop and S-Bup); the active ingredients contained in drug products. In these conditions, linearity over the concentration range, 1.0-10.0 µg/spot for each (R)-enantiomer and 1.0-8.0 µg/spot for 2,6-DMA main organic impurity were obtained. The detection limits are less than 0.6 µg/spot of chiral and organic impurities. The intra and inter-day assay precision was less than 3.0% (RSD%).
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DOI: 10.5155/eurjchem.5.2.214-218.964
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Citations
[1]. Zhijian Tan, Fenfang Li, Congcong Zhao, Yubin Teng, Yanfei Liu
Chiral separation of mandelic acid enantiomers using an aqueous two-phase system based on a thermo-sensitive polymer and dextran
Separation and Purification Technology 172, 382, 2017
DOI: 10.1016/j.seppur.2016.08.039
[2]. Shengqiang Tong, Hu Zhang, Jizhong Yan
Analytical Enantioseparation of β-Substituted-2-Phenylpropionic Acids by High-Performance Liquid Chromatography with Hydroxypropyl-β-Cyclodextrin as Chiral Mobile Phase Additive
Journal of Chromatographic Science 54(4), 593, 2016
DOI: 10.1093/chromsci/bmv192
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DOI Link: https://doi.org/10.5155/eurjchem.5.2.214-218.964
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European Journal of Chemistry 2014, 5(2), 214-218 | doi: https://doi.org/10.5155/eurjchem.5.2.214-218.964 | Get rights and content
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