摘要
目的 建立双塞通片中二羟基丙基茶碱的含量测定方法。方法 采用HPLC法 ,色谱柱为HypersilODS2柱 (2 5 0mm×4 .6mm ,5 μm) ,以甲醇 - 0 .0 1mol·L-1磷酸二氢钾溶液 (含 0 .1%三乙胺 ,用磷酸调pH 3.0 ) (2 5∶75 )为流动相 ,流速为 1.0ml·min-1,柱温为室温 ,检测波长 2 73nm。结果 二羟基丙基茶碱在 0 .2 0 0 2～ 1.0 0 1mg·ml-1范围内与峰面积呈良好的线性关系(r=0 .9998) ,日内精密度RSD =0 .10 % (n =9) ;日间精密度RSD =0 .13% (n =5 )。平均回收率为 99.7% ,RSD =0 .2 2 % (n =9)。结论 所用方法快速简便、灵敏、准确、精密度好 ,可用于双塞通片的质量控制。
OBJECTIVE To establish a determination method of diprophylline contents in Shuangsaitong tablets.METHODS HPLC method was adopted.The chromatographic system was composed of Hypersil ODS2 column (250 mm×4.6 mm,5 μm) and mobile phase consisted of methanol-0.01 mol·L -1 KH 2PO 4 (containing 0.1% triethylamine,pH 3.0 adjusted with H 3PO 4)(25∶75).The flow rate was 1.0 ml·min -1 with detective wavelength of 273 nm.RESULTS There was a good linear relationship for diprophylline within the range of 0.2002 to 1.001 mg·ml -1 (r=0.9998).The within-day precision RSD was 0.10%(n=9),and the inter-day precision RSD was 0.13%(n=5).The average recovery was 99.7% with the RSD of 0.22%(n=9).CONCLUSION The method is convenient,sensitive and reproducible.Therefore,it is suitable for the quality control of Shuangsaitong tablets.
出处
《华西药学杂志》
CAS
CSCD
2004年第4期288-289,共2页
West China Journal of Pharmaceutical Sciences
