Zinchenko I. Analytical support for pharmaceutical development, optimization of quality control methods and standardization of the semi-solid preparations with ketoprofen

Analytical procedures for identification and assay of ketoprofen, dexketoprofen and products of their decomposition by HPLC as well as methylsalicylate by HPLC, levomentol, ethanol and DMSO by GC were developed. The correctness of the procedures was proved by the validation results. The effect of stress factors on the stability of ketoprofen and dexketoprofen was investigated by HPLC, as well as the formation of ketoprofen esters in solutions with hydrophilic solvents, whose molecules contain hydroxyl group(s), and with levomenthol was studied. The procedures for identification and assay of ketoprofen esters with macrogol 400 and levomentod by HPLC with gradient elution were developed. The correctness of the procedures was proved by the validation results. The approach to the identification and assay of ketoprofen esters was substantiated. The approach to estimation of homogeneity of substances distribution in semi-solid preparations was substantiated. Analytical support of pharmaceutical development and standardization of NOBI GEL® gel 2,5 % (Ministry of Health of Ukraine (UA/15144/01/01) registered this product, its manufacture was started), Flamadex® gel 2,5 % and Zumba gel (the clinical trials of these products were successful, they are in the registration phase) as well as of Sustagard® Plus cream-gel. Registration documents were developed for these medicinal products