高原康胶囊中氨茶碱的溶出度测定

目的建立检查高原康胶囊中氨茶碱溶出度测定方法。方法根据《中国药典》2010年（二部）附录ⅩC第二法对其溶出度进行检查。采用水1000 ml为溶出介质,转速为50 r.min-1,取样时间为20 min,以十八烷基硅烷键合硅胶为填充剂,流动相：0.05 mol.L-1NaH2PO4（含三乙胺0.2%,用磷酸调pH 4.0）-甲醇（65∶35）;检测波长：245 nm;流速：1.0 ml.min-1;柱温：30℃。结果茶碱在0.015 08～0.1357 mg.ml-1范围内线性关系良好（r=1.0000）,平均回收率为99.39%,RSD为0.46%（n=9）。结论本方法简便、测定结果准确,可用于高原康胶囊的氨茶碱溶出度检查。

Dissolution Determination of Aminophylline in Gaoyuankang Capsules by HPLC

Objective To establish an HPLC method for the determination of dissolution of aminophylline in Gaoyuankang capsules.Methods Detection was carried out according to the procedure described in the second method in appendix ⅩC,second part of 2010 edition of Chinese Pharmacopoeia.The dissolution medium was water solution.The rotation speed was 50 r · min-1,sampling time 20 min,the analytical method was high efficiency liquid chromatography with Athena C18.The mobile phase was composed of 0.05 mol · L-1 sodium dihydrogen phosphate solution（containing 0.2%triethylamine with the pH value of mixture adjusted to 4.0 by phosphoric acid）-methanol（65∶ 35）.The flow rate was 1.0 ml · min-1,detection wavelength 245 nm,and the column temperature 30 ℃.Results The calibration curves of theophylline showed a good linear relationship in the range of 0.015 08-0.1357 mg · ml-1（r=1.0000）.The average recovery of theophylline was 99.39% and RSD was 0.46%（n=9）.Conclusion This method is reliable and accurate.It can be used for the determination of dissolution of aminophylline in Gaoyuankang capsules.