| 气相色谱法测定维生素K1注射剂中1，2-丙二醇的含量 |
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| 引用本文： | 李兰,刘雁鸣,龙海燕,彭琳,谢莹莹,陈得雨.气相色谱法测定维生素K1注射剂中1，2-丙二醇的含量[J].中南药学,2013(9):692-694. |
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| 作者姓名： | 李兰 刘雁鸣 龙海燕 彭琳 谢莹莹 陈得雨 |
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| 作者单位： | [1]中南大学药学院,长沙410013 [2]湖南药用辅料检验检测中心,长沙410014 |
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| 摘 要： | 目的建立GC法测定维生素K1注射剂中1，2-丙二醇的含量。方法采用Agilent DB—WAX气相毛细管柱（0．32mm×30m，0．25μm），FID检测器，程序升温：80℃维持1min，再以10℃·min^-1升温至230℃维持4min，进样口温度：230℃，检测器温度：250℃。结果维生素K1注射剂中1，2．丙二醇在0．1025～4．0998nag·mL^-1与峰面积呈良好线性关系（r=0．9999），平均回收率为97．5％，RSD为0．40％（n=9）。结论本方法准确度高、重现性好，可用于维生素K1注射剂中1，2-丙二醇含量的测定。
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| 关 键 词： | 气相色谱 维生素K1 注射剂 1 2-丙二醇 |
Determination of 1, 2-propylene glycol in Vitamin K1 injection by GC |
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| LI Lan,LIU Yan-ming,LONG Hai-yan,PENG Lin,XIE Ying-ying,CHEN De-yu.Determination of 1, 2-propylene glycol in Vitamin K1 injection by GC[J].Central South Pharmacy,2013(9):692-694. |
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| Authors: | LI Lan LIU Yan-ming LONG Hai-yan PENG Lin XIE Ying-ying CHEN De-yu |
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| Institution: | 1. School of Pharmacy, Central South University, Changsha 410013; 2. Hunan Pharmaceutical Excipients Testing and Inspection Center, Changsha 410014) |
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| Abstract: | Objective To establish a GC method to determine 1, 2-propylene glycol in Vitamin K1 injection. Methods The chromatographic separation was carried out on the capillary column Agilent DB-WAX （0.32 mm× 30 m, 0.25 μm）, and FID was used as the detector. The column temperature was 80 ℃ for 1 min and then rose to 230 ℃ at a rate of 10 ℃ .min^- 1, maintaining for 4 min. The temperature of the inlet and detector was 230 ℃ and 250 ℃, respectively. Results There was a good linear relationship of 1, 2-propylene glycol in Vitamin K1 injection between the peak area and concentration at 0.102 5 -- 4.099 8 mg ~ mL- ~ （r = 0.999 9）. The average recovery was 97.5% with RSD = 0.40% （n = 9）. Conclusion This method is reproducible and accurate to determine the content of 1, 2-propylene glycol in Vitamin K1 injection. |
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| Keywords: | GC Vitamin K1 injection 1 2-propylene glycol |
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