复方盐酸苯海拉明糖浆质量控制研究

Quality Control of Compound Diphenhydramine Hydrochloride Syrups

目的建立复方盐酸苯海拉明糖浆的质量控制方法。方法采用理化鉴别与薄层色谱（TLC）法对复方盐酸苯海拉明糖浆进行定性鉴别,用高效液相色谱（HPLC）法对盐酸苯海拉明进行含量测定。结果理化鉴别结果现象显著,薄层色谱斑点清晰、集中。盐酸苯海拉明进样量在4.032～14.112μg范围内与峰面积积分值呈良好线性关系（r=0.999 6）,平均加样回收率为98.80%,RSD=1.18%（n=9）。结论 TLC法和HPLC法准确、可靠,可用于复方盐酸苯海拉明糖浆的质量控制。

Objective To establish a quality control method for Compound Diphenhydramine Hydrochloride Syrups.Methods Physical Chemical Identity and TLC were adopted for conducting the qualitative identification of Compound Diphenhydramine Hydrochloride Syrups,HPLC was used to determine the content of Diphenhydramine Hydrochloride in this preparation.Results The results of Physical and Chemical Identification was significant.TLC spots were clear.A good linearity relationship with the peak areas was exhibited（r=0.999 6） when the sample size of Diphenhydramine Hydrochloride was in the range of 4.032-14.112 μg.The average recovery rate of diphenhydramine hydrochloride was 98.80%,RSD =1.18%（n =9）.Conclusion The method of TLC and HPLC is accurate and specific with good reproducibility.It can be used for the quality control of Compound Diphenhydramine Hydrochloride Syrups.