Development of methods for identification and quantitative determination of Analben in tablets

Abstract

PURPOSE: Analben has been created by the researchers of the National University of Pharmacy and recommended in the solid dosage form as a promising non-narcotic analgesic and anti-inflammatory drug. The aim of the work is to develop physico-chemical and chemical methods of identification and quantitative determination of the active pharmaceutical ingredient in Analben tablets. MATERIALS AND METHODS: As the object of research a pilot batch of tablets “Analben, 1 mg” produced by the pharmaceutical firm “Neopharm” together with the company “Zdorovie” was selected. Analytical studies were performed by the methods of spectrophotometry, thin-layer chromatography and chemical reactions. RESULTS AND CONCLUSIONS: As the result of the work performed, the spectral characteristics of the analben substance in various solvents have been studied, the optimal conditions for determining related impurities have been selected using the method of thin-layer chromatography. The pectrophotometric method for quantitative determination of Analben in the tablets under study has been developed; the solvent, concentration and wavelength have been chosen. The validation characteristics of the quantitative determination method have been studied and it has been determined that linearity is observed in the range of concentrations from 0.16 μg/ml to 0.24 μg/ml (±20%), the systematic error of the method (0.33%) is practically insignificant, the relative confidence interval for the value Z (0.62%) is less than the critical value for convergence of results (1.66%).