Development of Analytical Method for Determination of p-toluenesulfonylurea and its Impurities in Gliclazide Drug Substances by using HPLC

Abstract

A highly sensitive analytical method is developed to determine the p-toluenesulfonylurea (PTSU) and its impurities namely o-toluenesulfonamide (OTSA), p-toluenesulfonamide (PTSA) and p-toluenesulfonic acid (PTS) in Gliclazide drug substance by high performance liquid chromatography (HPLC). The developed method is validated according to the International Council for Harmonization (ICH) guidelines. The method is specific where peak purity is passing for all the impurities and were well separated. Limit of detection and limit of quantitation established for all the four impurities which is less 30% of target concentration of 0.1%. The regression coefficient found from linearity studies was greater than 0.9922 for all the four impurities. The % recovery obtained for all the impurities in Gliclazide was between 86.56% and 105.21%. Precision, repeatability and intermediate precision are established for the method by observing the relative standard deviation (RSD) which is less than 10%. The developed method can be adapted by quality control to determine and quantify these impurities in Gliclazide drug substance or drug product.