Development and validation of spectrophotometric method for quantitative determination of carvedilol in tablets

Abstract

INTRODUCTION: Carvedilol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. AIM: The aim of this article is to develop a spectrophotometric method for the quantitative determination of carvedilol with diazonium salts, establish optimal conditions for the quantitative determination of carvedilol in drugs, and validate the developed methodology. MATERIALS AND METHODS: All studies were conducted on the basis of the experimental pharmaceutical research department of the scientific medical laboratory center (NMLC) of the Zaporozhye State Medical University. Reagents and solvents: 6.25 mg carvedilol tablets (PRANAPHARMJSC, Samara, series 20717), 12.5 mg Carvedilol Canon tablets (Canonpharma Production CJSC, Russia, series 060517), 25 mg Talliton tablets (EGIS Pharmaceuticals PLC, Hungary, series 473D0617), 25 mg Carvedilol-KV tablets (OJSC Kyiv Vitamin Plant, Kyiv, Ukraine, series EF 411017), diazol red 2G (NVF Sinbias), acetone, methanol, ethanol, isopropanol, water. Analytical equipment: SPECORD-200spectrophotometer (Analytic Jena AG, Germany), ULAB S131UV spectrophotometer, RADWAG XA 210.4Y electronic laboratory scales, Sonorex Digitec DT100H ultrasonic bath. RESULTS: The technique of spectrophotometric determination of the quantitative content of carvedilol based on its reaction with red diazole in water-methanol medium has been developed. The 1:1 stoichiometric ratios of the reactive components were obtained by the methods of continuous changes and the saturation method. CONCLUSION: A spectrophotometric method of analysis for the quantitative determination of carvedilol in tablets has been developed. The method is simple, fast, accurate, and reliable. This has been proven by verification characteristics (linearity, precision, correctness and sustainability). The developed methodology is correct and can be used in the chemical and pharmaceutical industries.