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目的 :建立甲睾酮贴片的含量测定方法 ,并对其稳定性进行了考察。方法 :用RP HPLC测定甲睾酮贴片的含量 ,并对贴片进行了光照、高温、低温、常温和加速试验考察。结果 :线性范围 6 0～ 140 μg·ml-1,回收率为 10 0 .4% (n =6 ,RSD =0 .6 1% )。该制剂在常温、高湿、低温条件下稳定 ,高温和光照对本制剂的稳定性有一定影响。结论 :该制剂在常温、高湿、低温下稳定 ,应避免过热及光照。
OBJECTIVE: To establish a method for the determination of methyltestosterone patch and investigate its stability. Methods: RP-HPLC was used to determine the content of methyltestosterone patch, and the patch was subjected to light, high temperature, low temperature, room temperature and accelerated test. Results: The linear range was 60-140 μg · ml-1 and the recovery was 100.4% (n = 6, RSD = 0.61%). The preparation is stable under normal temperature, high humidity and low temperature, and high temperature and light have certain influence on the stability of the preparation. Conclusion: The preparation is stable at normal temperature, high humidity and low temperature. It should avoid overheating and light.