Bysaga E. Development and validation of the quality control methods of the extemporaneous preparations with procaine hydrochloride.

The thesis is devoted to the development and standardization of quality control methods for the extemporaneous preparations which contain procaine hydrochloride according to the requirements of the State Pharmacopoeia of Ukraine. Reliability of chemical reactions for the qualitative control has been studied at the first time by the means of validation. The optimal reactions of the identification of procaine hydrochloride were selected based on the results of researches. The calculation of validation parameters of analytical methods for the quantitative determination of procaine hydrochloride was done at first time according to the requirements of the State Pharmacopoeia of Ukraine. A modified spectrophotometric assay of procaine hydrochloride in extemporal solutions proposed and the optimal volumetric methods for assay of the procaine hydrochloride were selected. The method for the control of the content of excess stabilizer (hydrochloric acid) in the extemporal solutions of the procaine hydrochloride was proposed. The stability of the substance of procaine hydrochloride and its solutions during storage in the conditions of the drug-store was studied at the first time.