高效液相色谱法测定盐酸阿比朵尔片的含量及其有关物质

Determination of arbidol hydrochloride and its related substance in tablets by HPLC

目的：建立高效液相色谱（HPLC）法分离测定盐酸阿比朵尔片及其有关物质。方法：采用高效液相色谱紫外检测法测定盐酸阿比朵尔片的含量，检测波长：315nm；色谱柱：Alltech Apollo C18（5μm，250mm×4．6mm）；流动相：缓冲液为0．1％三乙胺水溶液（用磷酸调节pH2．0）-乙腈（52．5：47．5）；流速：1．0mL·min^-1，柱温：25℃，进样量：10μL。结果：在0．5～9．0mg·L^-1范围内，对照品溶液的浓度与峰面积呈良好的线性关系（r=0．9998），平均加样回收率为93．0％～99．9％，RSD为1．7％～2．4％。盐酸阿比朵尔与有关物质分离良好。结论：本法测定盐酸阿比朵尔片的含量及有关物质，方法简便，快捷，准确，专属性好。

OBJECTIVE To establish an HPLC method for determining abidol hydrochlorateide in tablets and its related substance by HPI,C. METHODS An high performance liquid chromatography with UV detection was adopted, the detection wavelength was 315 nrn. The sample was separated on Alltech Apollo C18 （5μm,250 mm × 4. 6 mm）, with 0. 1 % triethylamine （pH was adjusted to 2.0 using phosphoric acid）-acetonitrile （52.7：47. 5） as the mobile phase （flow rate 1.0 mL· min^-1 ）. The column temperature was 25℃. Injection volume was 10 μL. RESULTS A good linearity was obtained in the range of 0. 5 - 9. 0 mg·L^-1 （r = 0. 999 8） . The recoveries of arbidol was 93. 00%- 99. 9% and the RSD was 1.7%- 2. 4%. CONCLUSION This method is simple, accurate and can be used to assay arbidol hydrochloide and its related substances in the tablets.