复方盐酸特比萘芬凝胶的处方优选及含量测定

Preparation and content detection of compound terbinafine hydrochloride gel

目的优选复方盐酸特比萘芬凝胶的处方,并建立含量测定方法。方法以外观性状、涂展性、pH值、黏度值及低温实验结果为考察指标,进行处方筛选,并以高效液相法(HPLC)测定盐酸特比萘芬和糠酸莫米松的含量。结果处方中95%乙醇用量为30%,水为27.3%,聚山梨酯80为4%,二甲基亚砜为5%时凝胶性状良好,处方稳定;盐酸特比萘芬与糠酸莫米松含量测定专属性良好,精密度RSD分别为0.08%、0.07%,盐酸特比萘芬在40~280μg/ml浓度范围内,线性关系良好(r=0.9999);糠酸莫米松在4~28μg/ml浓度范围内,线性关系良好(r=0.9999)。加速实验6个月稳定。结论复方盐酸特比萘芬凝胶制备工艺简单,优化处方稳定可行,检测方法准确可靠,可用于生产过程的质量控制。

Objective To optimize the compound formulation of terbinafine hydrochloride gel and establish a method for the determination of terbinafine hydrochloride and mometasone furoate in the gel. Methods The formulation was screened according to the appearance,spreadability,pH value,viscosity value and low temperature test results. The contents of terbinafine hydrochloride and mometasone furoate were determined by high performance liquid chromatography(HPLC). Results When the ratio of 95% ethanol in the formulation was 30%,water was 27.3%,polysorbate 80 was 4%,and dimethyl sulfoxide was 5%,the gel properties were good and stable. The HPLC method for the determination of terbinafine hydrochloride and mometasone furoate showed a good specificity, with the precision RSD of 0.08% and 0.07%,respeclively. The method also showed a good linearity within the concentration range of 40-280 μg/ml(r=0.9999)for terbinafine hydrochloride and 4-28 μg/ml(r=0.9999)for mometasone furoate. The accelerated stability test showed that the gel was stable for 6 months. Conclusion The preparation of compound terbinafine hydrochloride gel was simple, the optimized formulation was stable and feasible,and the detection method was accurate and reliable,the detection method can be used for quality control in production process of the compound terbinafine hydrochloride gel.