苯海拉明软膏中盐酸苯海拉明的含量测定

摘要

Objective To establish a method to determine the contents of diphenhydramine hydrochloride in diphenhydramine ointment. Methods Linearity, precision and recovery between potassium chromate indicator method and acid-base titration method were compared. Results By potassium chromate indicator method, diphenhydramine hydrochloride yielded a linear range of 3.99~19.94 mg/ml (r=0.9999), with the average recovery of 97.15%and RSD of 1.59%. By acid-base titration, determination of diphenhydramine hydrochloride yielded a linear range of 4.06~20.32 mg/ml (r=0.9993), with the average recovery of 98.90%and RSD of 0.84%. Conclusion Acid-base titration method is accurate, reliable, and can be used for content determination of diphenhydramine hydrochloride in diphenhydramine ointment.%目的：建立苯海拉明软膏中盐酸苯海拉明的含量测定方法。方法比较铬酸钾指示剂法和酸碱滴定法的线性、精密度和回收率。结果铬酸钾指示剂法中，盐酸苯海拉明在3.99~19.94 mg/ml范围内有良好的线性关系， r=0.9999；平均回收率为97.15%， RSD为1.59%。酸碱滴定法中盐酸苯海拉明在4.06~20.32 mg/ml范围呈现良好的线性关系， r=0.9993；平均回收率为98.90%， RSD=0.84%。结论酸碱滴定法准确、可靠，可用于苯海拉明软膏中盐酸苯海拉明的含量测定。