THE ASSESSMENT OF THE METHOD FOR QUANTITATIVE DETERMINATION OF PREDNISOLONE IN THE OINTMENT BY THE REACTION WITH PHENYLHYDRAZINE
Adaptation and validation of the analytical method of photocolorimetric determination of prednisolone using the reaction with phenylhydrazine by the standard method have been carried out in the scientific research laboratory according to standard procedures as described in the State Pharmacopoeia of Ukraine. The main validation characteristics have been identified using the model solution with the standard substance. It has been found that the criteria of linearity and precision are observed in the range of concentrations of 80-120% (0.08-0.12 mg/ml in the test solution or 0.4-0.6% of prednisolone in the ointment), and they are statistically and practically insignificant (a a * 1.86 = 4.7, Aas% a * 1.86 = 4.4, Aas% < 3.20 = 2.71, 5 < 1.0240 = 1.00). The method is acceptable for use in laboratories of the drug quality control and could be applied for determination of prednisolone in “0.5% Prednisolone” ointment with the hydrophobic base within the range of concentrations of 0.4-0.6%.