| 引用本文: | 陈爽,楼永军.GC测定丙戊酸钠缓释片的有关物质[J].中国现代应用药学,2018,35(7):998-1000. |
| CHEN Shuang,LOU Yongjun.Determination of Related Substances in Compound Sodium Valproate and Valproic Acid SR Tablets by GC[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(7):998-1000. |
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| 摘要: |
| 目的 建立毛细管气相色谱法检测丙戊酸钠缓释片有关物质的方法。方法 采用聚乙二醇为固定液的HP-FFAP色谱柱（30 m×0.53 mm，1 μm），柱温为程序升温；氮气为载气，流速为10 mL·min-1；直接进样1.0 μL，进样口温度200℃；采用氢火焰离子化检测器，检测器温度250℃。结果 建立的方法专属性强，能有效分离丙戊酸钠缓释片中的10个杂质；丙戊酸在1.01~8.06 μg·mL-1内线性关系良好（r=0.998 2，n=5），最低检出限为0.403 μg·mL-1。方法重复性良好，各杂质加样回收率均>90%，且RSD均<5%。结论 该方法可用于丙戊酸钠缓释片的有关物质检测。 |
| 关键词: 丙戊酸钠缓释片 有关物质检测 气相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.07.011 |
| 分类号:R917.101 |
| 基金项目: |
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| Determination of Related Substances in Compound Sodium Valproate and Valproic Acid SR Tablets by GC |
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CHEN Shuang, LOU Yongjun
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Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To develop a capillary gas chromatography(GC) method for determination of related substances in Compound Sodium Valproate and Valproic Acid SR tablets. METHODS The CGC column was PEG-20M(HP-FFAP, 30 m×0.53 mm, 1 μm), temperature programming. N2 as carrier gas (flow rate:10 mL·min-1). The temperature of the injection port was maintained at 200℃, and that of the flame-ionization detector(FID) was 250℃. The injection volume was 1.0 μL. RESULTS The method was specific. Valproic acid had a good linear relationship in the range of 1.01-8.06 μg·mL-1(r=0.998 2, n=5) and the lowest limit of detection was 0.403 μg·mL-1. The relative recovery was >90%, and the RSD was <5%. CONCLUSION The method can be used for the determination of related substances in Compound Sodium Valproate and Valproic Acid SR tablets. |
| Key words: Compound Sodium Valproate and Valproic Acid SR tablets detection of related substances GC |
