Determination of Two Components in A-Liu Spitits and Their Stability under Different Storage Conditions / 中国药师

ABSTRACT

Objective:To establish an HPLC method for determining the content of aspirin and sodium salicylat in A-Liu spirits and study the stability of the two components under different storage conditions. Methods:The analytical column was Agilent Eclipse XDB-C18(150 mm ×4.6 mm, 5 μm) ,0.01 mol·L-1 potassium dihydrogen phosphate (adjusting pH to 2.3 with potassium acid) -acetonitrile-methanol(55∶15∶30) was used as the mobile phase at the flow rate of 1. 0ml·min-1 , the detection wavelength was 280 nm and the column temperature was 30℃. The contents of aspirin and sodium salicylat were regularly determined under such storage conditions as ambient temperature, constant temperature and humidity(30℃ ± 2℃,65% ± 5%) and refrigeration (4℃ ± 2℃). Re-sultsThe average recovery and RSD were 100. 06% and 0. 80%(n=9) for aspirin, and 100. 53% and 0. 82%(n=9) for sodium salicylat. Aspirin and sodium salicylat showed good linear relationship within the range of 31.0-310.0 μg·ml-1(r=0.999 9)and 30. 5-305. 0 μg·ml-1(r=0. 999 5), respectively. Under the three storage conditions, the content of aspirin was decreased, while that of sodium salicylat was increased, suggesting the temperature could significantly affect the hydrolysis rate and content of aspirin Conclusion:The method is promising with good resolution, reproducibility and sensitivity. It is recommended that the method be used to determine the content of aspirin and sodium salicylat in A-Liu spirits, and aspirin isn't stable under different storage conditions.