吡硫翁锌乳膏中吡硫翁锌的含量测定及其稳定性研究

Determination of Zinc Pythione in Zinc Pythione Cream and Study on Its Stability

目的:建立高效液相色谱(HPLC)法检测吡硫翁锌乳膏中吡硫翁锌含量方法,并研究其乳膏剂的稳定性。方法:采用有机溶剂提取吡硫翁锌乳膏中的吡硫翁锌,采用HPLC方法测定吡硫翁锌的含量,通过影响因素和加速实验考察吡硫翁锌乳膏剂的稳定性。结果:吡硫翁锌浓度在2～200 mg/L范围内呈良好的线性关系,定量限为0.35 mg/L,平均回收率为(100.48±0.14)%,吡硫翁锌乳膏对高温、高湿和强光较为稳定;在加速实验中,该乳膏不发生颜色变化,吡硫翁锌的含量在98%以上。结论:采用HPLC法可实现吡硫翁锌乳膏的定量研究,并有效测定吡硫翁锌的含量;砒硫翁锌乳膏较稳定,能够抵抗高温、高湿和强光的破坏作用。

Objective: To establish the determination of zinc pyrithione in zinc pyrithione cream by HPLC and tostudy on Its stability. Methods: The zinc pyrithione was extracted using organic solution, and the content of zinc pyrithi-one was determined by HPLC. Stability of zine pyrithione in the cream was evaluated by the stress tests and the acceler-ating test. Results: The calibration curves of zinc pyrithione showed good linearity in range between 2 and 200 mg/mL,and the limit of quantification was 0.35 mg/L. The average recoveries ranged from (100.48±0.14)%. Zinc pyrithione inthe cream was stable to the high temperatureand high humidity and intense light. During the accelerating test, the colorof cream was not changed and the content of zinc pyrithione was kept above 98%. Conclusion: HPLC method was de-veloped for testing the content of zinc pyrithione in the zinc pyrithione cream. And zinc pyrithione cream had a goodlong-term stability under the specified conditions.