Peleshok K. Development and Validation of Methods for the Analysis of Valsartan and Atenolol in Drugs

In the dissertation has provided an experimental study of the development of spectrophotometric and chromatographic methods for the determination of valsartan and atenolol in substances and drugs. The latest approaches to the development and validation of express analytical methods of quality control of API and dosage forms of valsartan and atenolol were demonstrated. The spectrophotometric methods for the determination of valsartan and atenolol in substances and drugs have been developed and validated. The possibility of using bromophenol blue and methyl red in the development of spectrophotometric methods for the determination of valsartan in substances and drugs has been established. The optimal conditions for the formation of products of interaction of valsartan with dyes - the choice of concentration of reagent, organic solvent; the coefficients of stoichiometric ratios "valsartan - reagent" were established. A spectrophotometric method for the simultaneous determination of valsartan and atenolol in binary mixtures and drugs was developed and validated. Chromatographic methods for the simultaneous determination of valsartan and atenolol in substances and drugs using TLC and HPLC methods were developed and validated (on Zorbax C8, Discovery C18, LiChrospher® 60 RP-select B chromatographic columns). The procedure of development of methods for quantitative determination of valsartan and atenolol for the assessment of in vitro equivalence using spectrophotometric and chromatographic methods was experimentally substantiated. In the process of performing the experimental part, the author developed and validated methods for determining valsartan to study permeability through the intestinal membrane. The original methods for the quantification of valsartan and atenolol for usage in the dissolution test have been developed. Based on the proposed principles and approaches, a method for isocratic chromatographic determination of valsartan and atenolol in drugs (Method I) (patent of Ukraine for the utility model № 146653 dated 10.03.2021), a method for isocratic chromatographic determination of valsartan and atenolol in drugs (Method II) (patent of Ukraine for the utility model № 145731 dated 29.12.2020), method of chromatographic determination of valsartan and atenolol in medicinal products (patent of Ukraine for the utility model № 145966 dated 14.01.2021) were developed.