HPLC法测定盐酸地芬诺酯的含量

Determination of Diphenoxylate Hydrochloride Content by HPLC

目的:建立盐酸地芬诺酯含量的高效液相色谱法。方法:采用CN柱(250×4.6mm);流动相:A相(庚烷磺酸钠27.5mg,三乙胺0.8ml,水1000ml用磷酸调pH值(3.00±0.02))-乙腈(25:75),检测波长为258nm;进样量10μl;柱温为35℃;流速:1ml/min。结果:样品线性范围:99.36μg/ml到894.24μg/ml,r=0.9999。回收率:99.52%,相对标准偏差1.0%。结论:此法简便,快速,准确,可行。

Objectives： To establish an HPLC method that to determine diphenoxylate hydrochloride. Method：The assay was performed on a Kromasil-CN column（250mm×4.6mm）;The mobile phase was composed of A（CH3（CH2）6SO3Na 27.5mg,Triethylamine phosphate 0.8ml,water 1000ml,then adjusting pH to（3.00±0.02））-acetonitrile（25：75）,The detection wavelength was 258nm,the flow rate was 1.0ml/min.The column temperature was 35℃.Results： Linear range： Diphenoxylate Hydrochloride showed good linear in the range of 99.36μg/ml to 894.24μg/ml（r=0.9999）.Conclusion： the method might be simple,rapid,accurate and feasible.