Quality Standard Improvement for Angelica Sinensis / 中国药师

ABSTRACT

Objective: To establish and optimize the HPLC fingerprints of Angelica sinensis medicinal material and determine the ligustilide content to improve the quality standard for Angelica sinensis and improve the quality control level of Chinese angelica medici-nal material and preparations. Methods: A method for the determination of ligustilide was optimized by HPLC. The column was eluted on an Agilent ZORBAX SB C18(250 mm×4. 6 mm, 5 μm) column with acetonitrile-water (60 ∶ 40) as the mobile phase. The flow rate was 1. 0 ml·min-1, the detection wavelength was 326 nm, and the column temperature was at 35 ℃. The HPLC fingerprints of 13 batches of Angelica sinensis from different origins and methodological investigations were established and validated to set up an HPLC fingerprinting evaluation method for Angelica sinensis. Acetonitrile-0. 1% formic acid was used as the mobile phase with gradient elu-tion. The flow rate was 1. 0 ml·min-1, the detection wavelength was 280nm, and the column temperature was at 25℃. Results: The results showed that under the above HPLC conditions, ligustilide had good linearity within the range of 0. 032 3-0. 645 5 mg·ml-1(r=0. 999 9), and the average recovery was 100. 5% (RSD=1. 61% ,n=6). The quality fraction of ligustilide in Angelica sinensis was 0. 885 6%-2. 382 2% . Through the establishment of HPLC fingerprints of Angelica sinensis, the characteristic profiles with better peak shape and degree of separation and 18 common peaks with better resolution were obtained. The similarities of the 13 batches of angelica were all between 0. 9 and 1. 0. Conclusion: According to the methodological investigation, the HPLC fingerprints and ligustilide con-tent determination method of Angelica sinensis are simple, reliable, stable and feasible.