Study on Quality Standard for Kazakhstan Medicine Peganum harmala / 中国药房

ABSTRACT

OBJECTIVE： To establish the quality standard for Kazakhstan medicine Peganum harmala. METHODS： Ten batches of P. harmala collected in Xinjiang Kazakh region were selected as research objects to investigate their characteristics. Qualitative identification of harmaline and harmine was conducted by TLC. The contents of water， total ash， acid-insoluble ash and ethanol extract were tested according to Chinese Pharmacopoeia（2015 edition）. The contents of harmaline and harmine were determined by HPLC. The determination was performed on X-bridge C18 column（250 mm×4.6 mm，5 μm） with mobile phase consisted of acetonitrile-ammonium acetate buffer （adjusted to 6 with glacial acetic acid， gradient elution） at the flow rate of 1 mL/min. The detection wavelength was set at 267 nm， and column temperature was 25 ℃. The sample size was 5 μL. RESULTS： TLC identification results showed that 10 batches of medicinal material showed clear spots at the same position as harmaline and harmine reference substances. Water， total ash， acid-insoluble ash should not be more than 12％，22％，2％， respectively； ethanol extract must not be less than 16％. HPLC results showed that the linear ranges of harmaline and harmine were 15.22-301.40，15.09-301.80 μg/mL； RSDs of precision， reproducibility and stability tests were all lower than 4％； average recoveries were 100.22％ and 100.94％（all RSD＜2％）. The determination results showed that the content of total alkaloids （harmaline and harmine） should not be less than 6.5 mg/g. CONCLUSIONS： Based on the original standard， test items are added in this study. TLC method is established to identify harmaline and harmine. HPLC method is established to determine their contents. Established quality standard can be used for comprehensive quality control of P. harmala from Xinjiang Kazakh region.