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Citation: YU Li-Ju, Huang Hai-Wei, LI Xiu-Mei, SHENG Jia, XU Yong-Wei, HE Lan. Determination of Stereoisomers in Landiolol Hydrochloride by Ultra Performance Convergence Chromatography[J]. Chinese Journal of Analytical Chemistry, ;2016, 44(9): 1348-1353. doi: 10.11895/j.issn.0253-3820.160128 shu

Determination of Stereoisomers in Landiolol Hydrochloride by Ultra Performance Convergence Chromatography

YU Li-Ju ^1, ,
Huang Hai-Wei ¹ ,
LI Xiu-Mei ² ,
SHENG Jia ³ ,
XU Yong-Wei ³ ,
HE Lan ¹

1.
National Institutes for Food and Drug Control, Beijing 100050, China
2.
Sanmenxia Food and Drug Inspection Center, Sanmenxia 472000, China
3.
Waters Technology Company, Shanghai 201206, China

Received Date: 25 February 2016
Revised Date: 13 April 2016

Fund Project: This work was supported by the National Science and Technology Major Projects for Major New Drugs Innovation and Development (No.2015ZX09303001).

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A new method for chiral separation and purity inspection of landiolol hydrochloride and its stereoisomers was developed by ultra-performance convergence chromatography (UPC²). The mobile phase was the mixture of supercritical CO₂ and methanol/n-butyl alcohol/acetonitrile (1:1:1, V/V) plus 0.5% NH₃·H₂O. The separation was carried out on the Daicel CHIRALPAK^®IF column (150 mm×4.6 mm, 3 μm) with a flow rate of 2.8 mL/min at 50℃ using 223 nm as detection wavelength. Under the optimized experimental conditions, for R,R-stereoisomer, R,S-stereoisomer and S,R-stereoisomer, the detection limits (LOD, S/N=3) were 0.3, 0.4 and 0.3 mg/L, the linear ranges were 2-300 mg/L, 5-300 mg/L and 2-300 mg/L, the recoveries of spike samples were 103.4%±2.5%, 91.8%±2.5% and 101.7%±1.5%, and the injection repeatabilities were 0.06%, 0.09% and 0.08% (n=6), respectively. The experimental results demonstrate that the UPC²-based method can be used for the analysis and determination of landiolol hydrochloride and its stereoisomers.
- Ultra performance convergence chromatography,
- Landiolol hydrochloride,
- Stereoisomers,
- Chiral separation
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