Physico-chemical characterization, analytical method development and solubility studies for progesterone

Abstract

Progesterone is a well known natural contraceptive, a drug of BCS class II, which was used in early centuries to protect from the side effects of estrogens like abortion. For the preformulation studies, the solubility of progesterone in various oils, solvents, surfactants and co-surfactants was determined for further formulation development. The Progesterone has been evaluated for XRD, DSC, Partition coefficient, melting point and its solubility is also checked in different solvents. Physico-chemical characterization studies showed that progesterone has a melting point of 1270C. The solubility of drug progesterone was evaluated in methanol, and ethanol. The analytical method developed for the estimation of progesterone in methanol and ethanol showed maximum absorbance at λmax of 241 nm and 247 nm respectively at pH 7.4.Linearity studies indicated that estimation of progesterone between 1.00 μg /ml to 10.00 μg /ml was found to be linear with regression equation of y = 0.0575x + 0.0041; R² = 0.9985 with methanol and y = 0.0442x+0.0041; R² = 0.9968 with ethanol. On the basis of solubility studies two oils with highest solubility (Oleic acid and Myritol), two surfactants (Tween80 and Tween20) and three co-surfactants (Ethanol, Propanol and PEG400) were selected respectively for further formulation studies. The above analytical parameters indicated that the developed UV Spectrophotometric method for progesterone was simple, accurate, precise and reproducible.