Abstract
The aim of the work. To develop a method for spectrophotometric determination of sotalol with diazonium salts. Establish optimal conditions for the quantitative determination of sotalol in drugs. Validate the developed methodology. Materials and methods. Reagents and solvents used in the study were: diazole red 2J (obtained from NVF “Sinbias”), tablets “Sotalol Sandoz” 40 mg (Salyutas Pharma GmbH, series JZ1188), “Sotalol Sandoz” 80 mg (Salyutas Pharma GmbH, series KA0464) and “Sotalol Sandoz” 160 mg (Salyutas Pharma GmbH, series JY3504), methanol (LAB-SCAN, Ireland, batch № 5120/13), sodium carbonate (Sinbias) and purified water were also used. Analytical equipment: spectrophotometer “SPECORD-200” (Analytic Jena AG, Germany), scales laboratory electronic RADWAG XA 210.4Y, bath ultrasonic Sonorex Digitec DT100H, laboratory glassware of class A. All studies were conducted in the experimental pharmaceutical research department of the scientific medical laboratory center (SMLC) of the Zaporizhzhia State Medical University. Results and discussion. The technique of spectrophotometric determination of the quantitative content of sotalol based on its reaction with red diazole in water-methanol medium has been developed. The stoichiometric ratios of the reactive components as 1:1 were obtained by the methods of continuous changes and the saturation method. Validation of the developed on such indicators as linearity, precision, correctness and robustness is carried out. Based on these data, the developed method is correct and could be used in the quality control departments of chemical and pharmaceutical companies. Conclusions. A method of quantitative spectrophotometric determination of sotalol in the tablet dosage form “Sotalol Sandoz” 40 mg, “Sotalol Sandoz” 80 mg and “Sotalol Sandoz” 160 mg of industrial production was developed, validation characteristics were investigated: linearity, precision, correctness, range of application and robustness
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