甲睾酮凝胶剂的制备与含量测定

Preparation and Content Determination of Methyltestosterone Gelatin

目的:制备甲睾酮凝胶剂,并建立其含量测定方法。方法:以甲睾酮为主药,卡波姆940、67%乙醇、肉豆蔻酸异丙酯等为基质,制备凝胶剂;采用高效液相色谱法测定甲睾酮的含量。结果:所制制剂为澄清透明凝胶;甲睾酮检测浓度的线性范围为2.0～8.0μg·mL-1,平均回收率为99.84%,RSD=0.62%(n=5)。结论:该制剂制备工艺可行,含量测定方法具有较好的专属性和精确度。

OBJECTIVE： To prepare Methyltestosterone gelatin and to establish its content determination method. METHODS： Gelatin was prepared using methyltestosterone as main component and carbomer 940, 67% ethanol and isopropyl myristate as matrix. The content of methyltestosterone was determined by HPLC. RESULTS： Preparation was colorless transparent gelatin. The linear range of methyltestosterone was 2.0～8.0 μg·mL-1 with an average recovery of 99.84% （RSD=0.62%,n=5）. CONCLUSION： Preparation method is practical. The content determination method is specific and accurate.