Study on Quality Standard of Oleanolic Acid Dripping Pills / 中国药房

ABSTRACT

OBJECTIVE:To establish the quality standard of Oleanolic acid dripping pills. METHODS:The property of the preparation was identified,and weight difference and dissolution time limit were detected. UPLC method was adopted to determine the content of oleanolic acid in the preparation. The determination was performed on ACQUITY UPLC BEH C18 column with mo-bile phase consisted of acetonitrile-water (7030,V/V) at the flow rate of 0.30 mL/min. The detection wavelength was set at 206 nm,the column temperature was 30 ℃,and the sample was 5 μL. RESULTS:The characteristics of the preparation was significant;weight difference ranged 37.62%-46.56%;dissolution time limit was 24 min. Linear range of oleanolic acid ranged 0.006-0.06 mg/mL (r=0.9998). RSDs of precision,stability and reproducibility tests were all lower than 2.0%. The recoveries were 99.34%-100.40%(RSD=0.4%,n=6). CONCLUSIONS:Established standard can be used for quality control of Oleanolic acid dripping pills.