Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, 71526 Assiut, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, 71526 Assiut, Egypt; Pharmacist in the General Eman Hospital, Assiut, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2020 Apr 5;230:118058. doi: 10.1016/j.saa.2020.118058. Epub 2020 Jan 21.
The study involves use of factorial design for optimization of forced degradation conditions and development of stability indicating method for medroxyprogestrone acetate (MPA) or depo-provera as known in the market. MPA is an important contraceptive and anticancer drug especially for treatment of breast cancer and it is the first time to study the different conditions affecting its stability. MPA was subjected to different variables such as solvent type, pH and the time subjected to UV light. Factorial design has been used during forced degradation to determine significant factors responsible for degradation and to optimize degradation conditions reaching maximum degradation. Factors responsible for forced degradation were statistically evaluated using Bubble and Surface plots. Variables proved to be significant (p < 0.05) and the suggested model represented a perfect example for indicating the efficiency of factorial designs in optimizing the degradation conditions that give maximum percent of degradation. We investigated also the solubility and stability profiles of MPA in aqueous solutions. Stability study results showed a very low stability profile of MPA in all the aqueous solutions with rapid degradation rate more than other solvents. The current research may contribute to enrich the knowledge of the physicochemical properties of this drug for exploring its full anticancer potential in the future.
该研究采用析因设计优化米非司酮（MPA）或醋酸甲羟孕酮（Depo-Provera，市场上的商品名）的强制降解条件，并开发出稳定性指示方法。MPA 是一种重要的避孕药和抗癌药物，特别是用于治疗乳腺癌，这是首次研究影响其稳定性的不同条件。MPA 经历了不同的变量，如溶剂类型、pH 值和暴露于紫外光的时间。在强制降解过程中使用析因设计来确定导致降解的重要因素，并优化降解条件以达到最大降解。使用气泡图和表面图对负责强制降解的因素进行了统计学评估。证明这些变量是显著的（p<0.05），所提出的模型是析因设计在优化降解条件方面的效率的一个很好的例子，这些降解条件可使降解百分比达到最大。我们还研究了 MPA 在水溶液中的溶解度和稳定性特征。稳定性研究结果表明，MPA 在所有水溶液中的稳定性都非常低，降解速度比其他溶剂快。这项研究可能有助于丰富该药物的物理化学性质的知识，为未来探索其抗癌潜力提供帮助。
