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目的建立反相高效液相色谱法测定乌金胶囊中延胡索乙素含量,并应用于该制剂质量控制。方法使用Agilent Extend-C18柱(4.6mm×250mm,5μm),甲醇-0.1%磷酸(以三乙胺调pH值至6.0)=5545为流动相,流速1.0ml/min,柱温35℃,检测波长280nm,测定5批次乌金胶囊中延胡索乙素含量。结果延胡索乙素在1.09～21.8μg/ml(r=0.999 9)范围内呈良好线性关系,平均加样回收率为98.62%,RSD=1.26%(n=6)。5批次乌金胶囊中延胡索乙素含量在15.87～50.57μg/g。结论反相高效液相色谱法灵敏、准确,适用于乌金胶囊中延胡索乙素的质量控制。
Objective To establish an RP-HPLC method for the determination of tetrahydropalmatine in Wujin Capsules and apply it to the quality control of this preparation. Methods The Agilent Extend-C18 column (4.6mm × 250mm, 5μm), methanol-0.1% phosphoric acid (adjusted to pH 6.0 with triethylamine) = 5545 was used as the mobile phase at a flow rate of 1.0ml / , Detection wavelength 280nm, determination of batches Wujin capsule Tetrahydropalmatine content. Results Tetrahydropalmatine had a good linearity in the range of 1.09-21.8μg / ml (r = 0.999 9). The average recoveries were 98.62% and RSD = 1.26% (n = 6). 5 batches of Wujin capsule tetrahydropalmatine content of 15.87 ~ 50.57μg / g. Conclusion RP-HPLC is sensitive, accurate and suitable for the quality control of tetrahydropalmatine in Wujin Capsules.