目的 建立測(cè)定注射用銀杏二萜內(nèi)酯中銀杏內(nèi)酯A、B、C、K的HPLC-ELSD法。方法 采用HPLC-ELSD法，Phenomenex Luna C18色譜柱（250 mm×4.6 mm，5 μm），流動(dòng)相為四氫呋喃–甲醇–水，梯度洗脫；體積流量為1.0 mL/min；柱溫為30 ℃；漂移管溫度為105 ℃，氮?dú)怏w積流量為3.0 L/min。結(jié)果 注射用銀杏二萜內(nèi)酯中銀杏內(nèi)酯A、B、C、K分別在1.70～8.50 μg（r＝0.999 7）、2.45～12.5 μg（r＝0.999 8）、0.30～1.50 μg（r＝0.999 7）、0.25～1.25 μg（r＝0.999 7）呈良好的線性關(guān)系；平均回收率分別為101.03%、100.86%、100.78%、101.02%，RSD值分別為0.87%、0.29%、1.30%、1.34%。結(jié)論 該方法簡(jiǎn)便準(zhǔn)確，重復(fù)性好，可用于注射用銀杏二萜內(nèi)酯中銀杏內(nèi)酯A、B、C、K的測(cè)定。

Objective To establish the method for determination of ginkgolide A, B, C, and K in Diterpene Lactones from Ginkgo biloba for injection by HPLC-ELSD. Methods HPLC-ELSD method was adopted. Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) was adopted with mobile phase consisted of tetrahydrofuran – methanol – water in gradient elution. The flow rate was 1.0 mL/min. The temperature of column and drift tube was set at 30 and 105 ℃, respectively. The flow rate of gas maintained at 3.0 L/min. Results The liner ranges of ginkgolide A, B, C, and K were 1.70 — 8.50 μg/mL (r=0.999 7), 2.45 — 12.5 μg/mL (r=0.999 8), 0.30 —1.50 μg/mL (r=0.999 7), and 0.25 — 1.25 μg/mL (r=0.999 7); The average recoveries were 101.03%, 100.86%, 100.78%, and 101.02%, with RSD values of 0.87%, 0.29%, 1.30%, and 1.34% (n=6), respectively. Conclusion The method could be used for the determination of ginkgolide A, B, C, and K in Diterpene Lactones from Ginkgo biloba for injection with a good sensitivity, accuracy, and reproducibility.

國(guó)家重大新藥創(chuàng)制項(xiàng)目（2013ZX09402203）