目的 采用高效液相色譜-電噴霧檢測器(HPLC-CAD)法同時測定小建中片中氧化芍藥苷、芍藥內(nèi)酯苷、芍藥苷、甘草苷、異甘草苷、桂皮酸、桂皮醛、甘草酸。方法 采用Agilent Zorbax Eclipse XDB C₁₈色譜柱(250 mm×4.6 mm,5μm);流動相:90%甲醇-10 mmol/L甲酸銨(甲酸調(diào)pH 3.5),梯度洗脫;體積流量:0.9 mL/min;柱溫:30℃;進樣量:20μL;CAD霧化器溫度:35℃,采集頻率為10 Hz,過濾常數(shù)為5.0。結(jié)果 氧化芍藥苷、芍藥內(nèi)酯苷、芍藥苷、甘草苷、異甘草苷、桂皮酸、桂皮醛、甘草酸的線性范圍分別為1.02~20.40、12.08~241.60、13.99~279.80、3.05~61.00、1.10~22.00、0.24~4.80、1.20~24.00、1.12~22.40μg/mL;平均加樣回收率分別為99.4%、97.1%、98.2%、98.9%、99.3%、97.5%、99.1%、98.8%,RSD值分別為1.8%、0.9%、1.8%、2.0%、2.3%、1.6%、2.0%、1.6%。結(jié)論 該方法同時測定小建中片中8個活性成分,實現(xiàn)多指標(biāo)成分質(zhì)量控制,為小建中片的質(zhì)量標(biāo)準(zhǔn)規(guī)范化研究提供參考。

Objective To develop HPLC-CAD method for simultaneous determination of oxypaeoniflora, albiflorin, paeoniflorin, liquiritin, isoliquiritin, cinnamic acid, cinnamaldehyde, and glycyrrhizic acid in Xiaojianzhong Tablets. Methods The chromatographic separation was performed on Agilent Agilent Zorbax Eclipse XDB C₁₈ column (250 mm×4.6 mm, 5 μm) with 90% methanol - 10 mmol/L ammonium acetate (formic acid tone pH 3.5) as the mobile phase for gradient elution. The flow rate was 0.9 mL/min, the column temperature was set at 30 ℃, and injection volume was 20 μL. The nebulization temperature of detector was set at 35 ℃, the acquisition frequency was 10 Hz, and the filtration constant was 5.0. Results The linear ranges of eight components were 1.02 — 20.40、12.08 — 241.60、13.99 — 279.80、3.05 — 61.00、1.10 — 22.00、0.24 — 4.80、1.20 — 24.00、1.12 — 22.40 μg/mL, respectively. The average recoveries were 99.4%, 97.1%, 98.2%, 98.9%, 99.3%, 97.5%, 99.1%, and 98.8%, and the RSD values were 1.8%, 0.9%, 1.8%, 2.0%, 2.3%, 1.6%, 2.0%, and 1.6%, respectively. Conclusion The method can simultaneously determine 8 active ingredients in Xiaojianzhong Tablets, and realizes the quality control of multi-index component, which provides a reference for the standardization research of Xiaojianzhong Tablets.

R286.02