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.PDF

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 1 1.0 mL·min ，检测波长210 ，254 nm 。结果 丙戊酸钠线性范围为 0.99~2.92 mg·mL (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。 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 中图分类号： R917.101 文献标志码：B 文章编号：1007-7693(2017)05-0711-04 DOI: 10.13748/ki.issn1007-7693.2017.05.017 引用本文：李树英, 王英新, 刘玲, 等. 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. 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 linea