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目的:建立HPLC法同时测定新癀片中8个成分(异嗪皮啶、迷迭香酸、三七皂苷R1、人参皂苷Rgl、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd、吲哚美辛)。方法:采用Agilent ZORBAX SB-C18色谱柱(4.6 mm×250 mm,5μm),以乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱(0~30 min,19.5%A;30~60 min,19.5%A→40%A;60~75 min,40%A→45%A;75~90 min,45%A→85%A;90~100 min,19.5%A),流速1.0 m L·min-1,检测波长为203 nm(三七皂苷R1、人参皂苷Rgl、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd)、254 nm(吲哚美辛)和342 nm(异嗪皮啶、迷迭香酸),柱温30℃。结果:异嗪皮啶、迷迭香酸、三七皂苷R1、人参皂苷Rgl、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd和吲哚美辛的线性范围分别为10.09~504.7、10.16~508.2、34.24~1 712、164.6~8 230、27.64~1 382、121.7~6 084、157.7~7 883和274.5~13 724 ng;平均加样回收率(n=3)分别为99.2%~100.3%、101.6%~103.5%、97.6%~98.1%、99.3%~100.7%、96.2%~98.8%、101.1%~102.5%、99.8%~100.8%和101.1%~101.8%,RSD均≤3.0%。3批样品中上述8个成分的含量范围分别为0.38~0.83、0.37~0.83、2.07~2.32、12.40~17.33、1.75~2.64、6.97~11.18、10.85~12.84和19.29~20.80 mg·g-1。结论:该方法操作简单,重复性好,为评价和控制新癀片的质量提供了可靠的方法。
OBJECTIVE: To establish a HPLC method for the simultaneous determination of eight components in new tablets (isopziparin, rosmarinic acid, notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, ginsenoside Rd, indomethacin ). Methods: The mobile phase was eluted with gradient elution (0 ~ 30 min, 19.5% A) using Agilent ZORBAX SB-C18 column (4.6 mm × 250 mm, 5 μm) 30-60 min 19.5% A 40% A 60-75 min 40% A 45% A 75-90 min 45% A 85% A 90- 100 min 19.5% A), flow rate 1.0 m L · min-1 and the detection wavelength was 203 nm (notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1 and ginsenoside Rd), 254 nm (indomethacin) and 342 nm Derridyl, rosmarinic acid) at a column temperature of 30 ° C. Results: The linear ranges of isopiramin, rosmarinic acid, notoginsenoside R1, ginsenoside Rgl, ginsenoside Re, ginsenoside Rb1, ginsenoside Rd and indomethacin were 10.09 ~ 504.7,10.16 ~ 508.2, 34.24 ~ 1 712,164.6 ~ 8 230,27.64 ~ 1 382,121.7 ~ 6 084,157.7 ~ 7 883 and 274.5 ~ 13 724 ng respectively. The average recoveries (n = 3) were 99.2% ~ 100.3% % To 103.5%, 97.6% to 98.1%, 99.3% to 100.7%, 96.2% to 98.8%, 101.1% to 102.5%, 99.8% to 100.8% and 101.1% to 101.8%, respectively. The contents of the above eight components in three batches of samples ranged from 0.38 to 0.83, from 0.37 to 0.83, from 2. 07 to 2.32, from 12.40 to 17.33, from 1.75 to 2.64, from 6.97 to 11.18, from 10.85 to 12.84 and from 19.29 to 20.80 mg · g -1, respectively. Conclusion: The method is simple and reproducible, which provides a reliable method for evaluating and controlling the quality of new tablets.