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肌醇烟酸酯片质量标准提升研究

刘尧,王磊,崔浩,马郑   

  1. 大连市药品检验所,大连市药品检验所,大连市药品不良反应监测中心,大连市药品检验所
  • 收稿日期:2018-02-24 修回日期:2018-02-24 出版日期:2018-06-25 发布日期:2018-06-25
  • 基金资助:
    2017年国家评价性抽验品种

The Improvement of Quality Standard for Inositol Nicotinate Table

Liu Yao,, and   

  1. Dalian Institute for Drug Control,Dalian Institute for Drug Control,,
  • Received:2018-02-24 Revised:2018-02-24 Online:2018-06-25 Published:2018-06-25

摘要: 目的:研究提高肌醇烟酸酯片的质量标准。方法:采用RP-HPLC法,色谱条件为C18色谱柱,流动相:pH 6.0磷酸盐缓冲液-乙腈(70∶30,v/v)为流动相;检测波长262 nm。进样量20 μL。结果:该法专属性良好,线性范围为0.3005~21.04 μg?mL-1,相关系数:r=0.9998。平均回收率为100.1%。该法同时用于有关物质的检查。检出限为9.02×10-5mg?mL-1,定量限浓度为30.05×10-5mg?mL-1。强制降解实验结果表明,RP-HPLC专属性良好。结论:该法专属性强、灵敏可靠,适用于肌醇盐酸酯片的质量控制。

Abstract: Objective: To improve the standard of the quality control for inositol nicotinate table. Methods:The method was conducted by HPLC with C18 column and the wavelength set at 262 nm. The mobile phase was consisted of phosphate buffer (adjust pH to 6.0)- acetonitrile (70∶30, v/v). The injection volume was 20μL. Results:The method showed good specificity with a good linear relationship (r=0.9998). The liner range was 0.3005-21.04 μg?mL -1. The average recovery of the method was 100.1%. The method can both be uesd for the determination of the related substances in inositol nicotinate table.The detection limit was 9.02×10-5 mg?mL -1 and the quantitation limit was 30.05×10-5 mg?mL-1. Conclusion: The established method exhibits good selectivity and sensitivity and is proved to be suitable for the improvement of the standard of the quality control for inositol nicotinate table.