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

Shekhar Sharma, Anupama Diwan, Rupali Kalra, Vandana Arora


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.


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