离子色谱法测定丙戊酸钠片的含量  

Content Determination of Sodium Valproate Tablets by Ion Chromatography

作　　者：宋玉琴 赵昌军 

机构地区：[1]淄博市食品药品检验所,山东淄博255086

出　　处：《中国药房》2014年第25期2383-2385,共3页China Pharmacy

摘　　要：目的：建立丙戊酸钠片的含量测定方法。方法：采用离子色谱一抑制电导检测法。以Ion Pac AS19阴离子交换色谱柱进行分离，10mmol／L KOH溶液为淋洗液，加水抑制模式，抑制电流为20mA，电导池温度为35℃，柱温为30℃，进样量为25μl。测定3批样品的含量并与《中国药典》标准方法（双相酸碱滴定法）比较测定结果。结果：丙戊酸钠检测质量浓度线性范围为5．118～102．4ug／ml（r=0．9999），检测限和定量限分别为93、307ng／ml，平均回收率为98．77％（RSD=0．80％，n=6）。本方法与标准方法比较结果差异无统计学意义。结论：该方法准确、灵敏、简便，可用于丙戊酸钠片的质量控制。OBJECTIVE： To establish the method for the content determination of Sodium valproate tablets. METHODS： The ion chromatography-suppressed conductivity detection was adopted. The separation was performed on an Ion Pac AS19 anion exchange column eluted with 10 mmol/L potassium hydroxide solution. The suppression current was 20 mA with water suppressed pattern, the temperature of conductance cell was set at 35 % ; the column temperature was 30 ℃, and sample size was 25 μl. The contents of 3 batches of samples were compared between by the method and by two phase acid-base titration method stated in Chinese Pharmacopeia. RESULTS： The linear range of sodium valproate were 5.118-102.4μg/ml （r=0.999 9）. The limit of detection was 93 ng/ml and the limit of quantification was 307 ng/ml. The average recovery was 98.77% （RSD=0.80%, n=6）. There was no statistical significance between the method and standard method. CONCLUSIONS： The method is accurate, sensitive and simple, which can be used for the quality control of Sodium valproate tablets.

关 键 词：离子色谱 抑制电导检测 丙戊酸钠片 含量测定 

分 类 号：R95[医药卫生—药学]