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目的建立测定丙戊酸钠注射液中丙戊酸钠含量的高效液相色谱法。方法采用ZORBAXExtent-C18(4.6mm×250mm,5μm)色谱柱,甲醇-0.05mol·L-1磷酸二氢钾缓冲液(80∶20)用10%磷酸调pH值至5.0±0.05为流动相,检测波长为210nm。结果丙戊酸钠在0.9322~9.3223mg.mL-1内浓度与峰面积呈良好的线性关系,r=0.9999(n=6);平均回收率为100.37%,RSD为0.8%(n=9)。结论该方法准确可靠,重复性好,操作简便快速,可用于丙戊酸钠注射液中丙戊酸钠的含量测定。
Objective To establish a HPLC method for the determination of sodium valproate in sodium valproate injection. Methods The mobile phase consisted of ZORBAXExtent-C18 (4.6 mm × 250 mm, 5 μm), methanol-0.05 mol·L-1 potassium phosphate monobasic buffer (80:20), pH adjusted to 5.0 ± 0.05 with 10% The detection wavelength is 210nm. Results The concentration of sodium valproate showed a good linear relationship with the peak area in the range of 0.9322 ~ 9.3223mg.mL-1, r = 0.9999 (n = 6), the average recovery was 100.37% and the RSD was 0.8% . Conclusion The method is accurate, reliable, reproducible, and easy to operate. It can be used in the determination of sodium valproate in sodium valproate injection.