反相高效液相色谱法测定槐定碱滴丸体外溶出度

DETERMINATION OF DISSOLUTION RATE OF SOPHORIDINE DROPPING PILLS BY RP-HPLC

目的：建立测定槐定碱滴丸中槐定碱溶出度的方法。方法：选用小杯法,以0.1mol/L盐酸为溶出介质,转速为50 r·min-1,用高效液相色谱法测定槐定碱的溶出度,绘制溶出曲线,计算溶出参数T50、Td、m,并用相似因子法进行评价。结果：槐定碱的检测浓度在6.25-100μg·mL-1（r=0.9997）范围内与其峰面积积分值呈良好的线性关系；槐定碱的平均回收率为98.23%（RSD=2.17%）,3批样品溶出度相似。结论：本方法简便、准确、可靠,可用于测定槐定碱滴丸中主要组分的溶出度。

Objective：To determine the dissolution rates of Sophoridine in Sophoridine dropping pills. Methods：The smal 1 glass cup method was adopted in which 0. 1 mol/Lhydrochloric acid was taken as solvent with a rotating speed of 50 r · min-1 . The dissolution rates of Sophoridine were determined by RP-HPLC. The dissolution curves were drawn,and the dissolution parameters including T50 ,Td,and m were computed and evaluated using similar factors method. Results：The Sophoridine were linear over the range of 6 . 25 -100μg · mL-1 （ r=0 . 9997 ） . The average recoveries of the ingredients were 98 . 23%（ RSD=2 . 17%） . The three batches samples were proved to be of similar dis-solution rates. Conclusion：The determination method is simple, accurate and reliable, which can be applied to determine the dissolution rates of Sophoridine in Sophoridine dropping pills simultaneously.