RP-HPLC法同时测定复方异林苯明片中两种组份的含量

目的建立复方异林苯明片含量的测定方法。方法色谱柱为Zorbax SB-C18(4.6×250mm,5μm),流动相为甲醇-0.02moL.L-1磷酸二氢钾溶液(含0.1%高氯酸和0.1%三乙胺)(40?50);检测波长为219nm;流速为1.0mL.min-1;柱温为40℃。结果异丙安替比林和盐酸苯海拉明线性范围分别为2.48~19.85mg.mL-1(r=0.9998)和0.24~1.91mg.mL-1(r=0.9999),定量限分别为1.94ng和3.72ng,平均回收率分别为100.4%和99.8%(n=9)。结论该方法简便、快速、准确,可同时测定复方异林苯明中的2种组分的含量。

Determination of 2 components in Compound Propyphenazone Tablets by RP-HPLC

OBJECTIVE To establish an HPLC method for the simultaneous determination of the contents of propyphenazone and diphenhydramine hydrochloride in compound propyphenazone. METHODS Chromatography was performed on a Zorbax SB--C18 column（250mm × 4.6mm, 5μm） at 40℃ ;The mobile phase consisted of methanol -0.02mol·L^-1 potassium dihydrogen phosphate（containing 0. 1% perchloric acid and 0. 1% triehtylamine）（40 ： 50）at a flow rate of 1.0mL.min^-1 ; The detection wavelength was 219nm. RESULTS The liner range of propyphenazone and diphenhydramine hydrochloride were 2.48-19.85mg·mL^-1 （ r =0. 9998） and 0. 24-1.91mg·mL^-1 （ r =0. 9999） respectively. The detection limit were 1.94ng and 3. 72ng respectively. The average recovery（ n = 9） of two components were 100. 4 %,99. 8% respectively. CONCLUSION The method was rapid,accurate and reliable for the quality control of this compound preparation.