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

Simultaneous Determination of Valproate Sodium and Preservative in Sodium Valproate Oral Solution by HPLC

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

Key words:  valproate sodium  oral solution  preservative  sodium methylparaben  sodium propylparaben  content determination  HPLC

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^-1（r=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^-1（r=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^-1（r=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。

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.