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Determination of Enantiomeric Impurity in Besifloxacin Hydrochloride by Chiral High-Performance Liquid Chromatography With Precolumn Derivatization

Determination of Enantiomeric Impurity in Besifloxacin Hydrochloride by Chiral High-Performance Liquid Chromatography With Precolumn Derivatization

Zhangting Wang, Shengjia Wang, Feng Zhu, Zaixin Chen, Lushan Yu, Su Zeng

Chirality. 2012 Jul;24(7):526-31.

PMID: 22593028

Abstract:

Besifloxacin hydrochloride is a novel chiral broad-spectrum fluoroquinolone developed for the treatment of bacterial conjunctivitis. R-besifloxacin hydrochloride is used in clinics as a consequence of its higher antibacterial activity. To establish an enantiomeric impurity determination method, some chiral stationary phases (CSPs) were screened. Besifloxacin enantiomers can be separated to a certain extent on Chiral CD-Ph (Shiseido Co., Ltd., Japan), Chiral AGP, and Crownpak CR (+) (Daicel Chemical IND., Ltd., Japan). However, the selectivity and sensitivity were both unsatisfactory on these three CSPs. Therefore, Chiral AGP, Chiral CD-Ph, and Crownpak CR (+) were not used in the enantiomeric impurity determination of besifloxacin hydrochloride. The separation of enantiomers of besifloxacin was further performed using a precolumn derivatization chiral high-performance liquid chromatography method. 2,3,4,6-Tetra-O-acetyl-beta-D-glucopyranosyl isothiocyanate was used as the derivatization reagent. Besifloxacin enantiomer derivates were well separated on a C(18) column (250 × 4.6 mm, 5 µm) with a mobile phase that consisted of methanol-KH(2)PO(4) buffer solution (20 mM; pH 3.0) (50:50, v/v). Selectivity, sensitivity, linearity, accuracy, precision, stability, and robustness of this method were all satisfied with the method validation requirement. The method was suitable for the quality control of enantiomeric impurity in besifloxacin hydrochloride.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP1398566432	Besifloxacin hydrochloride		1398566-43-2	Price

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