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HPLC法测定浓维磷糖浆3种成分的含量

Determination of 3 components in concentrated divitamins and sodium phosphate syrup by HPLC

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【作者】 章为李文波王皖李帅李晓燕刘雁鸣曾令贵

【Author】 ZHANG Wei;LI Wenbo;WANG Wan;LI Shuai;LI Xiaoyan;LIU Yanming;ZENG Linggui;Hunan Institute for Drug Control;Xiangya School of Pharmaceutical Sciences,CSU;The Third Xiangya Hospital,CSU;

【机构】 湖南省药品检验研究院中南大学湘雅药学院中南大学湘雅三医院

【摘要】 目的:建立同时测定浓维磷糖浆中咖啡因、维生素B1和烟酸含量HPLC方法。方法:采用Ulti Mate XB-C18柱(4.6 mm×250 mm,5μm)色谱柱;以0.1%辛烷磺酸钠(含0.1%磷酸)为流动相A、乙腈为流动相B,梯度洗脱;流量1.0 m L·min-1;柱温30℃;检测波长261 nm。结果:咖啡因、维生素B1和烟酸的线性范围分别为38.22382.25μg·m L-1(r=1.000 0)、7.2872.75μg·m L-1(r=0.999 5)和0.787.84μg·m L-1(r=1.000 0);平均回收率(n=9)分别为99.3%、99.8%、98.6%,RSD分别为0.66%、1.14%、1.30%;170批样品含量测定结果为咖啡因0.28%0.33%、维生素B1 0.026%0.078%和烟酸0.004 6%0.0259%(g·m L-1)。结论:所建方法经方法学验证,可用于浓维磷糖浆的质量控制。

【Abstract】 Objective: To develop an HPLC method for the determination of Caffeine,Vitamin B1 and Niacin in Concentrated Divitamins and Sodium Phosphate Syrup. Methods: The test was performed on Ulti Mate XB-C18( 4. 6 mm × 250 mm,5 μm) column. The gradient elution was used with 0. 1% sodium octane sulfonate( with 0. 1% phosphoric acid) solution as mobile phase A and acetonitrile as mobile phase B. The flow rate was set as 1. 0 m L·min-1,column temperature as 30 ℃ and detection wavelength as 261 nm. Results: The linearity ranges of Caffeine,Vitamin B1 and Niacin fell into 38. 22-382. 25 μg·m L-1( r =1. 000 0),7. 28-72. 75 μg·m L-1( r =0. 999 5) and 0. 78-7. 84 μg·m L-1( r =1. 000 0) respectively. The average recoveries( n =9) of Caffeine,Vitamin B1 and Niacin were99. 3%,99. 8% and 98. 6% with RSD as 0. 66%,1. 14% and 1. 30%,respectively. The contents of Caffeine,Vitamin B1,and Niacin in 170 batches of samples were 0. 28%-0. 33%,0. 026%-0. 078% and 0. 004 6%-0. 0259%( g·m L-1). Conclusion: The methodology validation results show that the established method can be used for the quality control of Concentrated Divitamins and Sodium Phosphate Syrup.

  • 【文献出处】 中国药品标准 ,Drug Standards of China , 编辑部邮箱 ,2018年01期
  • 【分类号】O657.72;R927.2
  • 【被引频次】1
  • 【下载频次】106
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