复方威利宁滴鼻剂质控方法研究

Study of Quality Control Method for Compound Weilining Nose Drops

目的 :建立复方威利宁滴鼻剂的质控方法。方法 :采用一阶导数分光光度法在224 7nm波长处测定威利宁的含量。结果 :威利宁溶液在5～20μg/ml浓度范围内浓度 (C)与振幅 (D)线性关系良好 ,其回归方程为C=—1 3438 +520 78D(r=0 9998) ,平均回收率为100 35 % (n=9) ,相对标准差为0 87 %。结论 :本制剂制备容易 ,质量稳定 ;

OBJECTIVE:To establish the quality control method for compound Weilining nose drops.METHODS:First order derivation spectrophotometry was used to determine the content of Weilining in nose drops at wavelength224.7nm.RESULTS:A linearity of concentration(C)and amplitude(D)of Weilining solution was found in range of5～20μg/ml with a regression equation of C=—1.3438+520.78D;(r=0.9998),The average recovery rate was100.35%(n=9),RSD=0.87%.CONCLUSION:The Weilining nose drops is simple in preparation and stable in quality,and this method can be used for quality control of the preparation.