Factorial approach for the optimization and development of stability indicating study of the contraceptive suspension for injection(Depo-Provera®).

Affiliation

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, 71526 Assiut, Egypt. Electronic address: [Email]

Abstract

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.

Keywords

Anticancer drugs,Factorial design,Kinetic study,Medroxyprogesterone acetate,UV-degradation,