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目的:建立RP-HPLC同时测定复方双花咀嚼片中绿原酸、咖啡酸、连翘苷、穿心莲内酯和脱水穿心莲内酯的方法。方法:采用RP-HPLC法,依利特C18色谱柱(4.6 mm×250 mm,5μm);流动相乙腈(A)-0.2%甲酸(B),梯度洗脱(0~8 min,4%~13%A;8~24 min,13%~14%A;24~25 min,14%~26%A;25~65 min,26%~33%A;65~70 min,33%~50%A),流速1 m L·min-1,检测波长240 nm,柱温30℃。结果:绿原酸、咖啡酸、连翘苷、穿心莲内酯和脱水穿心莲内酯分别在0.282 5~2.825 0μg(r=0.999 5),0.086 8~0.867 5μg(r=0.999 7),0.480 0~4.800 0μg(r=0.999 5),0.158 8~1.587 5μg(r=0.999 5),0.148 8~1.487 5μg(r=0.999 4)呈良好的线性关系,平均回收率分别为97.3%,RSD 1.2%;97.8%,RSD 1.1%;98.9%,RSD 1.4%;97.6%,RSD 1.0%;99.0%,RSD 1.5%。结论:该方法简洁、可靠、专属性强,可用于复方双花咀嚼片的质量控制。
Objective: To establish a method for the simultaneous determination of chlorogenic acid, caffeic acid, forsythin, andrographolide and dehydroandrographolide in compound Shuanghua chewable tablets by RP-HPLC. Methods: The elution C18 column (4.6 mm × 250 mm, 5 μm) was used in the RP-HPLC method. The mobile phase consisted of acetonitrile (A) -0.2% formic acid (B) % A; 8-24 min 13% -14% A 24-25 min 14-26% A 25-65 min 26-33% A 65- 70 min 33-50% A ), Flow rate 1 m L · min-1, detection wavelength 240 nm, column temperature 30 ℃. RESULTS: The concentrations of chlorogenic acid, caffeic acid, forsythin, andrographolide and dehydroandrographolide were in the range of 0.282 5-2.825 0 μg (r = 0.999 5), 0.086 8-0.867 5 μg (r = 0.999 7), 0.480 0 ~ (R = 0.999 5), 0.148 8 ~ 1.487 5 μg (r = 0.999 4). The average recoveries were 97.3%, RSD 1.2%, respectively. 97.8%, RSD 1.1%, 98.9%, RSD 1.4%, 97.6%, RSD 1.0%, 99.0%, RSD 1.5%. Conclusion: The method is concise, reliable and specific and can be used for the quality control of Compound Shuanghua chewable tablets.