Content determination of obeticholic acid tablets by HPLC

Abstract

In order to establish a method for the content determination of obeticholic acid tablets, HPLC-UV method is adopted. The determination is performed on Agilent HC-C18 column（250 mm×4.6 mm,5 μm） with mobile phase acetonitrile (002% formic acid)-water (0.02% formic acid) = 60∶40 (V/V) at the flow rate of 1.0 mL/min. The detection wavelength is 195 nm, the column temperature is 30 ℃ and the volume is 100 μL. The result shows that there is a good liner relationship between the mass concentration of obeticholic acid in the range of 0.200 26~1.001 30 mg/mL and the peak area, and r=0.999 9. The RSD of precision, stability and reproducible tests are all less than 1.0%. The average recovery rate is 99.64% , and RSD is 0.58%(n=9). The method is simple, exclusive, accurate and durable, and can be used for the content determination of obeticholic acid tablets.

Keywords

• medicinal chemistry
• chromatography
• obeticholic acid
• HPLC
• ultraviolet detector
• content determination