Determination of R-valsartan in Valsartan Active Pharmaceutical Ingredients by Ultra Performance Convergence Chromatography

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 5X−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.