Saenko A.Yu. 1
Petrov A.Yu. 1
Kompantsev V.A. 1
Stepanova E.F. 1
Kul I.Ya. 1
1 Pyatigorsk Medical-Pharmaceutical Institute - branch of SBEE HPE VolgSMU of Minzdrav of Russia
There was developed the technology of suppositories with cinnarizine and succinic acid, there were also chosen the optimal base and auxiliary substance. By the method of dialysis through a semipermeable membrane it was established that the maximum release of cinnarizine was observed from suppositories, prepared on the polyethyleneoxide basis with 3% propylene glycol. There was developed the methodology of identification of cinnarizine and the product of its destruction and succinic acid by the method of chromatography in a thin layer of the sorbent. Solvent system n-propanol - aqua ammonia 25 % (7:3) was selected as optimal. There was developed the method of quantitative analysis of cinnarizine in suppositories by the spectrophotometric method at the wavelength of 253 nm. We conducted the validation assessment of spectrophotometric analysis of cinnarizine and succinic acid in suppositories according to the following indices: linearity, precision, accuracy. It was established that according to all indices the technique met the requirements. We carried out the standardization of suppositories according to the following indices: description, identity, time of dissolving, melting point, homogeneity of mass, foreign impurities, quantitative content of cinnarizine and succinic acid. There was set up an expiry date for suppositories – 2 years.