Stability of 0.1% w/w mometasone furoate in a cream formulation in aluminum tubes or plastic bottles was studied. The samples were stored at 25±2℃/60±5%RH condition and assayed at three months intervals for one year for long term stability testing. The samples were also stored at 40±2℃/75±5%RH condition and assayed at two month intervals for six
months for accelerated stability testing. A HPLC system with reverse phase column was used to assay the stability samples. The results were analyzed by the least squares linear regression and the lower 95% confidence intervals were also calculated. The shelf life of the cream formulation in either tubes or bottles is estimated over two years. 本研究旨在探討Mometasone Furoate在塑膠瓶裝及鋁質軟管裝乳膏劑中之藥品安定性及其架儲期之研究。本研究將不同包裝之Mometasone Furoate儲存在25±2℃/60±5%RH環境下一年,並在每三個月取樣一次來分析其藥品含量以評估其長期安定性。此外,本研究也將不同包裝之Mometasone Furoate在40±2℃/75±5%RH環境下儲存
6個月並每2個月取樣一次,以評估其加速安定性。所得到的含量數據以線性回歸及95%信賴區間之統計方式作分析,顯示Mometasone Furoate乳膏劑無論在塑膠瓶裝或鋁質管內皆具有超過兩年之藥品架儲期。