摘要
目的:建立元胡止痛缓释片中欧前胡素和延胡索乙素的HPLC含量测定方法。方法:采用Dikma Diamonsil C_(18)色谱柱(250 mm×4.6 mm,5μm),以0.1%磷酸溶液(用三乙胺调pH至6.0)-甲醇(30:70)为流动相,检测波长为284 nm,流速为1.0 ml·min^(-1),柱温为50℃,同时测定欧前胡素和延胡索乙素的含量。结果:在此色谱条件下,欧前胡素和延胡索乙素的分离度为3.62;延胡索乙素浓度与峰面积在4.64～13.92μg·ml^(-1)内线性关系良好(r=0.999 9),平均回收率为97.16%,RSD=1.35%(n=6);欧前胡素浓度与峰面积在2.32～6.96μg·ml^(-1)内线性关系良好(r=0.999 8),平均回收率为96.22%,RSD为1.68%(n=6)。结论:本方法准确可靠,灵敏度高,快速简便,可用于元胡止痛缓释片的质量控制。
Objective：To establish an HPLC method for the determination of tetrahydropalmantin and imperatiorin in Yuanhu Zhitong sustained release tablets.Method：A Dikma Diamonsil C_（18）（250 mm×4.6 mm,5μm） column was used with 0.1%phosphoric acid and methanol（30：70,adjusting pH to 6.0 with triethylamine ） as the mobile phase.The detection wavelength was at 284 nm and the flow rate was 1.0 ml · min^（18）.The column temperature was 50℃.Result：Under the chromatographic conditions,the resolution between tetrahydropalmatine and imperatorin was 3.62.The relationship between the concentration（C） and the peak area（A） of tetrahydropamalmtine and imperatorin was good linearity.The linear range of tetrahydropalmatine was within 4.64-13.92μg· ml^（-1） and the regression equation was A = 23.935 C ＋ 6.320（r=0.999 9）.The recovery of tetrahydropalmatine was 97.16%with RSD of 1.35%（n =6）.The linear range of imperatorin was within 2.32-6.96μg· ml^（-1） and the regression equation was A = 16.043 C ＋ 1.800（r = 0.9998）.The recovery of imperatorin was 96.22%with RSD of 1.68%（n = 6）.Conclusion：The method is accurate, sensitive and rapid,and could be used in the quality control of Yuanhu Zhitong sustained release tablets.
出处
《中国药师》
CAS
2012年第12期1746-1748,共3页
China Pharmacist
