RP-HPLC Method for the Determination of Ursodeoxycholic Acid in Ursodeoxycholic Acid Capsule / 中国药房

ABSTRACT

OBJECTIVE: To determine the content of Ursodeoxycholic acid in Ursodeoxycholic acid capsules by RP-HPLC.METHODS: HPLC was performed on Merck Lichrospher100 C18 column(125 mm?4.0 mm,5 ?m).The mobile phase was acetonitrile-0.002 mol?L-1 sodium dihydrogen phosphate solution(50∶50)(adjust pH2.0 with NaOH) at a flow rate of 1.0 mL?min-1.The detective wavelength was set at 205 nm.RESULTS: The calibration curve of Ursodeoxycholic acid was linear within the range of 0.25～1.00 mg?mL-1(r=0.999 7).The average recovery was 99.5% and RSD was 0.9%(n=9).CONCLUSION: This method is simple,feasible and reproducible,and it can be used for the quality control of Ursodeoxycholic acid capsules.