目的 建立HPLC法同時(shí)測(cè)定祖師麻凝膠膏劑中瑞香苷、瑞香素-8-O-β-D-葡萄糖苷、祖師麻甲素和7-羥基香豆素。方法 采用HPLC法，Prodigy ODS（3）色譜柱（250 mm×4.6 mm，5 μm）；流動(dòng)相為甲醇-0.05%磷酸溶液（18：82）；檢測(cè)波長(zhǎng)327 nm；柱溫35℃；體積流量1.0 mL/min；進(jìn)樣量10 μL。結(jié)果 瑞香苷、瑞香素-8-O-β-D-葡萄糖苷、祖師麻甲素和7-羥基香豆素的線性范圍分別為0.105 7~1.268 4、0.092 2~1.106 4、0.060 5~0.726 0、0.050 5~0.606 0 μg，r值均大于0.999 9；各成分的平均回收率分別為97.22%、99.27%、98.78%、99.45%，RSD值分別為1.01%、1.10%、1.40%、1.67%。結(jié)論 建立的方法簡(jiǎn)便、準(zhǔn)確、靈敏度高、重復(fù)性好，為建立可靠的祖師麻凝膠膏劑質(zhì)量標(biāo)準(zhǔn)、更好更全面地控制制劑質(zhì)量提供了數(shù)據(jù)支撐。

Objective To develop an HPLC method for simultaneous determination of daphne glycoside, daphnetin-8-O-β-D-glucoside, daphnetin, and 7-hydroxycoumarin in Zushima Gel Ointment. Methods The HPLC method was used on Prodigy ODS(3) column (250 mm×4.60 mm, 5 μm). The mobile phase was consisted of methanol-0.05% phosphoric acid (18:82). The detection wavelength was set at 327 nm. The temperature of column was set at 35℃, the flow rate was 1.0 mL/min, and the volume of injection was 10 μL. Results The linear ranges of daphne glycoside, daphnetin-8-O-β-D-glucoside, daphnetin, and 7-hydroxycoumarin were 0.105 7-1.268 4 μg, 0.092 2-1.106 4 μg, 0.060 5-0.726 0 μg, and 0.050 5-0.606 0 μg, respectively, with r values above 0.999 9. The average recoveries were 97.22%, 99.27%, 98.78%, and 99.45% with RSD values of 1.01%, 1.10%, 1.40%, and 1.67%, respectively. Conclusion The method is simple, accurate, sensitive, and reproducible, and at the same time, it provided data support for establishing a reliable quality standard of Zushima Gel Ointment, and controlling the quality of the preparations better and more comprehensively.

R284.1

廣州市科技計(jì)劃項(xiàng)目（201902010012）