Abstract:

To establish a simple RP-HPLC method for determination the content of terberine hydrochloride in Modified Pulsatilla granule. HPLC method was used. The HPLC system consisted of Ture Kromasil C18 column (4.6 mm×250 mm, 5 μm) and acetonitrile-0.03 mol/L phosphoric acid (30:70, v:v) mixture as the mobile phase,with a flow rate of 1.0 mL/min. The detection wavelength was 265 nm. The column temperature was maintained at 30℃. The excipients and solvents in the granule could be well separated from the drug under such a designated chromatogram condition and did not interfere with the assay. A good linear relationship was found between peak area and the concentration of berberine hydrochloride in the range of 93.00-186.00 μg/mL (r=0.9997, n=6). The average recovery was 99.49%, and RSD was 0.76% (n=6). The established approach was specific, accurate, reliable, prompt, sensitive and applicable. It can be used to control the quality of Modified Pulsatilla granule.