高效液相色谱法测定妇康阴道泡腾片中没食子酸和盐酸小檗碱的含量_药学论文.docVIP

高效液相色谱法测定妇康阴道泡腾片中没食子酸和盐酸小檗碱的含量_药学论文 高效液相色谱法测定妇康阴道泡腾片中没食子酸和盐酸小檗碱的含量_药学论文 作者：黄毅，康爱荣，闫明，徐芳，严欢，姜丽娟，仲婕，王新堂 【关键词】 高效液相色谱法 　　摘要: 目的: 建立妇康阴道泡腾片中没食子酸和盐酸小檗碱的含量测定方法。 方法: 采用高效液相色谱法，色谱柱为岛津Shampack VP ODS柱，测定没食子酸的流动相为0.2%甲醇的乙腈溶液-含0.1%三乙胺的0.1%磷酸水溶液（3∶97），检测波长为270nm;测定盐酸小檗碱的流动相为乙腈-含0.1%三乙胺的0.05mol#12539;L-1 磷酸二氢钾水溶液（25∶75），混合后用磷酸调pH=3，检测波长为345nm。 结果: 没食子酸在0.02604～0.20832μg范围内呈良好的线性关系，r=0.9996，平均回收率为97.89%，RSD=1.27%（n=6）。盐酸小檗碱在0.01956～0.1956μg范围内呈良好的线性关系，r=0.9998，平均回收率为98.98%，RSD=1.39%（n=6）。 结论: 该法简单、快速、专属性强、重现性好，能够较好地控制产品的质量。 　　关键词: 高效液相色谱法; 没食子酸; 盐酸小檗碱; 妇康阴道泡腾片 Determination of gallic acid and berberine hydrochloridein Huichun vaginal effervescent tablets by HPLC Abstract: Objective:To establish the methods for the determination of gallic acid and berberine hydrochloride in Huichun vaginal effervescent tablets.Methods:The separation was performed on Shimadzu Sham-pack VPS（150×4.6，5μm）column.The mobile phase of gallic acid was acetonitrile（with0.2%methonal）-0.1%phasphoric acid（with0.1%triehylamine）（3∶97）.The mobile phase of berberine hydrochloride was acetonitrile-0.05mol#12539;L-1 potassium dihydrogen phosphate（with0.1%triehylamine）（25∶75，mixture and adjust pH to3.0with phasphoric acid）.The column temperature of gallic acid was35℃was25℃of berberine hydrochloride.The detection wavelength of gallic acid was at270nm，and was at345nm of berberine hydrochloride.Results:The linear of gallinic acid was in the range of0.02604～0.20832μg，r=0.9996.The average recovery was97.89%and RSD was1.27%（n=6）.The linear of berberine hydrochloride was in the range of0.01956～0.1956μg，r=0.9998.The average recovery was98.98%and RSD was1.39%（n=6）.Conclusion:The mothed is convient，rapid，relible and accurate.It can be used for quality control of Huichun vaginal effervescent tablets. 　　Key words: Huichun vaginal effervescent tablets; Gallic acid; Berberine hydrochloride 　　妇康阴道泡腾片是由没食子、黄连、菝葜、石榴皮等药材经粉 碎后制成的泡腾片，对多种类型的阴道炎均有效。处方中黄连的主要成分为盐酸小檗碱，有多味药材中含有没食子酸。为更好地控制其质量，本研究采用HPLC法测定了本品中没食子酸和盐酸小檗碱的含量，为本品的定量分析提供