HPLC法同时测定喜炎平注射液中4个有效成分的含量  被引量:9

HPLC simultaneous determination of four effective ingredients in Xiyanping injection

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作  者:詹惠中[1,2] 陈伟康 肖小武[1,2] 杨小玲 罗跃华[1,2] 

机构地区:[1]江西省食品药品检验所,南昌330029 [2]南昌大学药学院,南昌330046 [3]江西青峰药业有限公司,赣州341000

出  处:《药物分析杂志》2012年第1期140-143,共4页Chinese Journal of Pharmaceutical Analysis

基  金:国家"重大新药创制F"科技重大专项(2001ZX09201-201-4)

摘  要:目的:建立高效液相色谱法同时测定喜炎平注射液中4个有效成分的含量。方法:采用Diamonsil C18(250 mm×4.6 mm,5μm)色谱柱,以磷酸二氢钾缓冲液(每1000 mL水中加入磷酸二氢钾1.361 g与庚烷-1-磺酸钠1.0 g)为流动相A,乙腈为流动相B,进行梯度洗脱,流速1.0 mL.min-1,检测波长225 nm,柱温25℃。结果:穿心莲内酯硫酸酯化物A、穿心莲内酯硫酸酯化物B、穿心莲内酯硫酸酯化物C、9-脱氢-17-氢-穿心莲内酯进样浓度分别在31.53~63.05μg.mL-1(r=0.9999),31.35~62.70μg.mL-1(r=0.9998),31.90~63.80μg.mL-1(r=0.9999),31.32~62.65μg.mL-1(r=0.9999)范围内线性关系良好;平均回收率(n=9)分别在98.2%~100.5%之间。结论:该方法准确,灵敏度高,可作为控制喜炎平注射液质量标准控制的方法。Objective:To develop an HPLC method for simultaneous determination of four effective ingredients in Xiyanping injection. Methods: Analysis was performed on a Diamonsil C18(250 mm ×4. 6 mm,5 μm) column eluted with water containing potassium dihydrogen phosphate and heptane - 1 - sulfonic acid sodium (A) and acetonitrile (B) in a gradient program. The flow rate was 1.0 mL · min^ -1, the detection wavelength was 225 nm, and the column temperature was 25 ℃. Results: Andrographolide sulfate A ( ASA ), andrographolide sulfate B ( ASB ), andrographolide sulfate C ( ASC ) and 9 - dehydro - 17 - hydro - andrographolide (DHA) showed good linearity in the ranges of 31.53 - 63.05μg · mL^- 1 ( r = 0. 9999 ), 31.35 - 62.70μg · mL^- 1 ( r = 0. 9998 ), 31.90 - 63.80 μg · mL^- 1 ( r = 0. 9999 ), and 31.32 - 62. 65μg · mL^- 1 ( r = 0. 9999 ). The average recoveries, measured at three concentration levels,varied from 98.2% to 100.5%. Conclusion:The method is simple, sensitive and accurate,which can be used for the quality control of Xiyanping injection.

关 键 词:喜炎平注射液 穿心莲内酯硫酸酯化物 脱氢穿心莲内酯 总磺化物 高效液相色谱法 中药多组分分析 

分 类 号:R917[医药卫生—药物分析学]

 

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