Study on the Quality Standard for Peganum Harmala Alkaloids Cream / 中国药师

ABSTRACT

Objective:To establish the quality standard for peganum harmala alkaloids cream ( CAPH) . Methods: The general quality of CAPH was inspected according to the general notices described in Chinese Pharmacopoeia volumeⅠ2010 edition. The qual-itative identification was carried out by TLC with harmine and harmaline as the index ingredients. The content determination was carried out by HPLC methods with harmine, harmaline and vasicine as the index ingredients. Results:The inspection items were all met the requirements. The experimental samples and the reference substances in TLC showed the identical spots with the same color and shape at the same position. The calibration curve of harmaline, harmine and vasicine was linear within the concentration range of 3. 440-110. 000 μg·ml-1 , 3. 340-107. 000 μg·ml-1 and 1. 380-22. 000 μg·ml-1 , respectively. The recovery was 98. 1%, 99. 8% and 99. 3% with RSD of 1. 75%, 1. 78% and 1. 95%, respectively (n=6). Conclusion: The established quality control methods meet the requirements of methodology, and the results lay foundation for the quality standard for CAPH.