Abstract:
An analytical method based on the ultra performance convergence chromatography (UPCC) has been established for the separation and detection of the enantiomer
R-valsartan in valsartan raw materials, and the main influencing factors have been discussed. A polysaccharide-derived chiral column (CHIRALPAK IC-3, 100 mm×3.0 mm, 3 μm) was used with methanol (containing 0.5% ethanolamine)∶carbon dioxide as the mobile phase and an isocratic elution at a flow rate of 1 mL/min with a detection wavelength of 230 nm and a dynamic back pressure (ABPR) of 13.79 MPa. The
R-valsartan was effectively isolated in the range of 10.072~100.720 μg/mL, the linear regression equation was
Y=428.910 5
X−1.059 8 (
r=0.998 0,
n=7), the detection limit was 3.357 μg/mL, and the average recovery rate was 104.35% (
n=9). The detection and analysis method of
R-valsartan by UPCC was established, which is fast, efficient, economical and environmentally friendly, and provides a new method and idea for the determination of
R-valsartan in valsartan raw materials.