| 引用本文: | 张佳茹,王晗,陈玉双,房冉,郑玉林.维生素B1有关物质检测方法的研究与应用[J].中国现代应用药学,2020,37(20):2487-2492. |
| ZHANG Jiaru,WANG Han,CHEN Yushuang,FANG Ran,ZHENG Yulin.Research and Application of Detection Methods for Vitamin B1 Related Substances[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(20):2487-2492. |
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| 摘要: |
| 目的 建立一种高效液相色谱法对维生素B1片剂和原料药有关物质进行检测。方法 采用Waters液相色谱柱Symmetry C18（250 mm×4.6 mm，5 μm），流动相A为4.045 g·L-1庚烷磺酸钠溶液（含1%三乙胺，用磷酸调节pH至3.5），流动相B为甲醇-乙腈（1：1），采用梯度洗脱，波长为254 nm，流速为1.0 mL·min-1。结果 分离度溶液中各杂质之间分离度均>1.5，片剂辅料不干扰8个已知杂质出峰，各已知杂质检测限为0.005~0.015 μg·mL-1；在高温、高湿、光照条件下杂质H和未知杂质均有不同程度增长。结论 该方法可以同时运用于维生素B1原料药和片剂的有关物质检测，维生素B1片应在阴凉干燥避光的条件下保存。 |
| 关键词: 维生素B1 维生素B1片 有关物质 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.20.010 |
| 分类号:R917.101 |
| 基金项目: |
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| Research and Application of Detection Methods for Vitamin B1 Related Substances |
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ZHANG Jiaru1, WANG Han1, CHEN Yushuang2, FANG Ran1, ZHENG Yulin2
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1.Shanghai University of Engineering Science, Shanghai 201620, China;2.Shanghai Maple Biological Technology Co., Ltd., Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method for the determination of vitamin B1 tablets and active pharmaceutical ingredient related substances. METHODS Waters liquid chromatography column Symmetry C18(250 mm×4.6 mm, 5 μm) was used. Mobile phase A was 4.045 g·L-1 sodium heptane sulfonate solution (containing 1% triethylamine, pH adjusted to 3.5 with phosphoric acid), mobile phase B was methanol-acetonitrile (1:1). Gradient elution was used with a wavelength of 254 nm and a flow rate of 1.0 mL·min-1. RESULTS The resolution of each impurity in the resolution solution was >1.5. Excipients in tablets didn't interfere with the peaks of 8 known impurities. Limit of detection of each impurity was in the range of 0.005-0.015 μg·mL-1. It was found that the impurity H and the unknown impurity increased in different degrees under various conditions. CONCLUSION The method can be applied to the detection of related substances of vitamin B1 active pharmaceutical ingredient and tablets. Vitamin B1 tablets shall be stored under the conditions of cool, dry and dark. |
| Key words: vitamin B1 vitamin B1 tablets related substances HPLC |
