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引用本文:李树英,王英新,刘玲,吴学萍,王文笙,何淑旺.HPLC同时测定丙戊酸钠口服溶液中丙戊酸钠及防腐剂的含量[J].中国现代应用药学,2017,34(5):711-714.
LI Shuying,WANG Yingxin,LIU Ling,WU Xueping,WANG Wensheng,HE Shuwang.Simultaneous Determination of Valproate Sodium and Preservative in Sodium Valproate Oral Solution by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(5):711-714.
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HPLC同时测定丙戊酸钠口服溶液中丙戊酸钠及防腐剂的含量
李树英, 王英新, 刘玲, 吴学萍, 王文笙, 何淑旺
山东达因海洋生物制药股份有限公司, 山东 荣成 274300
摘要:
目的 建立HPLC同时测定丙戊酸钠口服溶液中丙戊酸钠及防腐剂含量的方法。方法 采用Thermo Hypersil BDS C18色谱柱(250 mm×4.6 mm,5 μm),以0.01 mol·L-1磷酸二氢钠(磷酸调节pH为2.3)-乙腈(63∶37)为流动相,流速1.0 mL·min-1,检测波长210,254 nm。结果 丙戊酸钠线性范围为0.99~2.92 mg·mL-1r=0.999 9),平均回收率为98.8%(RSD=0.5%);羟苯甲酯钠线性范围为14.74~58.96 μg·mL-1r=0.999 9),平均回收率为100.8%(RSD=0.4%);羟苯丙酯钠线性范围为10.21~20.41 μg·mL-1r=0.999 9),平均回收率为101.1%(RSD=0.8%)。结论 该方法简单、迅速、可靠,可用于丙戊酸钠口服溶液的检测和质量控制。
关键词:  丙戊酸钠  口服溶液  防腐剂  羟苯甲酯钠  羟苯丙酯钠  含量测定  高效液相色谱法
DOI:10.13748/j.cnki.issn1007-7693.2017.05.017
分类号:
基金项目:山东省自主创新及成果转化专项项目(2015ZDXX0302A02)
Simultaneous Determination of Valproate Sodium and Preservative in Sodium Valproate Oral Solution by HPLC
LI Shuying, WANG Yingxin, LIU Ling, WU Xueping, WANG Wensheng, HE Shuwang
Shandong Dyne Marine organism Pharmaceutical Co. Ltd., Rongcheng 264300, China
Abstract:
OBJECTIVE To establish an HPLC method for simultaneous determination of valproate sodium and antiseptic in sodium valproate oral solution. METHODS Thermo Hypersil BDS C18 chromatographic column(250 mm×4.6 mm, 5 μm) was used. The isocratic elution was adopted, with the mobile phase composed of PBS (pH 2.3)-acetonitrile(63:37). The flow rate was 1.0 mL·min-1 and the detective wavelength was 210 and 254 nm. RESULTS The linear range of valproate sodium was 0.99-2.92 mg·mL-1 and the regression coefficient was 0.999 9. The recovery was 98.8%(RSD=0.5%). The linear range of sodium methylparaben was 14.74-58.96 μg·mL-1 and the regression coefficient was 0.999 9. The recovery was 100.8% (RSD=0.4%). The linear range of sodium propylparaben was 10.21-20.41 μg·mL-1 and the regression coefficient was 0.999 9. The recovery was 101.1%(RSD=0.8%). CONCLUSION The method is simple, quick and reliable. It can be used for actual test and quality control of sodium valproate oral solution.
Key words:  valproate sodium  oral solution  preservative  sodium methylparaben  sodium propylparaben  content determination  HPLC
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