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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 C_(18)色谱柱(250 mm×4.6 mm,5μm),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 m L·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·m L~(-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14.74~58.96μg·m L~(-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10.21~20.41μg·m L~(-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。
Objective To establish a method for simultaneous determination of sodium valproate and preservatives in sodium valproate oral solution by HPLC. Methods A Thermo Hypersil BDS C_ (18) column (250 mm × 4.6 mm, 5 μm) was used with 0.01 mol·L -1 sodium dihydrogen phosphate (pH adjusted to 2.3 by phosphoric acid) -acetonitrile (63:37) The mobile phase was flow rate 1.0 m L · min ~ (-1) and the detection wavelength was 210 and 254 nm. Results The linear range of sodium valproate was 0.99 ~ 2.92 mg · m L -1 (r = 0.999 9) with an average recovery of 98.8% (RSD = 0.5%). The linear range of sodium paraben was 14.74 ~ The average recovery was 100.8% (RSD = 0.4%), and the linear range was 10.21 ~ 20.41μg · m L ~ (-1) with the concentration of sodium dithiophosphate being 58.96μg · m L -1 (r = 0.999 9) (r = 0.999 9). The average recovery was 101.1% (RSD = 0.8%). Conclusion The method is simple, rapid and reliable and can be used for the detection and quality control of sodium valproate oral solution.