Content Determination of Ursodeoxycholic Acid Tablets by HPLC-CAD

OBJECTIVE To establish an HPLC-CAD method for determination of content of ursodeoxycholic acid tablets. METHODS A Sunfire C₁₈column(4.6 mm×250 mm, 5 μm) was used, the mobile phase was 0.1% formic acid-acetonitrile-methanol(32:58:10) and the flow rate was 1.0 mL·min^-1 with column temperature of 35℃. CAD detector parameters:the nebulization temperature was 35℃, with power function value of 1.6 and collection frequency of 10 Hz. RESULTS Ursodeoxycholic acid could be well separated with adjacent impurities. The linearity was good in the range of 0.05-1.0 mg·mL^-1(r²=0.999 7). The recoveries of ursodeoxycholic acid of the low, medium and high three concentrations were 99.6%, 99.9% and 99.9%, respectively. The contents of ursodeoxycholic acid in three batches of samples were 99.7%, 100.3% and 99.8% respectively, and there was no significant difference compared with the original standard method. CONCLUSION HPLC-CAD method is simple, specific and sensitive, which can be used as the quality control and evaluation method of ursodeoxycholic acid tablets.