盐酸特比萘芬凝胶剂的紫外分光光度法测定及方法学研究

Determination of UV-spectrophotomery method of hydrochloric terbinafine and studying of methodology

[目的]建立紫外分光光度法测定盐酸特比萘芬凝胶剂中盐酸特比萘芬(terbinafine)的含量。[方法]精密称取盐酸特比萘芬标准品10mg置50mL容量瓶中,用适量异丙醇超声溶解后加异丙醇至刻度,摇匀,于波长285nm处进行测定。标准曲线的建立:盐酸特比萘芬标准品(纯度为99.78%)105℃干燥1h后,取出放入保干器中放置20min备用。精密称取干燥至恒重的盐酸特比萘芬标准品10mg置50mL容量瓶中,加异丙醇至刻度溶解摇匀,再精密移取上述溶液1.0、2.0、3.0、5.0、6.0mL分别置于25mL容量瓶中,以异丙醇定容至刻度,摇匀,在285nm处测定吸收度,得回归方程为:A=-0.00093+0.0248C285,r=0.999777。[结果]盐酸特比萘芬在8～48μg/mL范围内有良好的线性关系。平均回收率=95.53%。[结论]方法快速、简便、准确。

[ Objective] To establish an UV - spectrophotomery method for the determination of hydrochloric terbinafine in hydrochloric terbinafine gel. [ Methods] Precisely sampling the standard hydrochloric terbinafine 10 mg into 50 mL capacity bottle, ultrasonic dissolving in appropriate isopropanol, added isopropanol to scale, shook up, the concentration of hydrochloric terbinafine was measured at 285 nm wavelength. The establishment of standard curve： After dried the standard hydrochloric terbinafine（purity equals 99.78%） 1 h at 105 centigrade, sampling and storing it in exsiccator 20 min, stand. Precisely sampling the standard hydrochloric terbinafinel0mg that was dried till constant weight into 50 mL capacity bottle, added isopropanol to scale, dissolved and shook up, sampling that solution 1.0,2.0,3.0,5.0,6.0 mL separately into 25 mL capacity bottle, added isopropanol to scale, shook up and determinated A at 285 nm. Regression equation： A = -0.000 93 ＋ 0.024 8 C2ss r = 0.999 777. [Results] The calibration curve was linear within the range of 8 -48 μg/mL. Recovery of the mean equals 95.53%. [Conclusion] The method is rapid,simple and accurate.