复方北豆根安酚那敏片质量标准的修订研究

目的建立复方北豆根安酚那敏片中马来酸氯苯那敏的含量测定方法。方法采用HPLC法对制剂中马来酸氯苯那敏进行含量测定。色谱条件：十八烷基硅烷键合硅胶为填充剂的色谱柱；甲醇旬．01mol／L磷酸二氢钾（5：95）溶液为流动相；检测波长为210nm；柱温为40℃；流速为1ml／min；进样量为20μl。结果马来酸氯苯那敏在0．1471～1．0294μg范围内具有良好的线性关系（Y=2242404．616X＋2508，r=0．9999）。平均回收率是101．87％（n=9）。实验的精密度、稳定性、重现性都很好。结论高效液相色谱法简便快速、精密度高、准确度好，可用于该药的含量测定。

Study on the standard of fufang beidougen anfennamin pian

Objective To establish the method of the content determination for Enalapril Maleate Capsules in Fufang Beidougen Anfennamin Pian. Methods The contents of Enalapril Maleate Capsules in Fufang Beidougen Anfennamin Pian were determined by HPLC. HPLC analytical method was carried out using a C18 column and a mixture containing 5 volume of methanol and 95 volume of 0. 01% phosphoric acid as the mobile phase . The detection wavelength was set at 210 nm. Results The calibration curves was linear in the range of 0. 1471 - 1. 0294 μg for chlorphenamine （Y = 2242404. 616X ＋ 2508, r = 0. 9999 ）. The average recovery was 101.87 % （ n = 9 ）. The precision, stability, and reproducibility of the experiment were very good. Conclusions In HPLC ,it is simple, quick, high precise and accurate to determine the content for Enalapril Maleate Capsules in Fufang Beidougen Anfennamin Pian.