Abstract
A simple, reliable and sensitive analytical method was developed and validated for the quantitative determination of organic impurity 4-amino benzene sulphonamide in sulphonamide hydrochloride by high performance liquid chromatography (HPLC) with UV-visible and photo-diode array (PDA) detector. It is challenging to develop and validate method on gradient elution with shortest run time and the lesser elution. The RP-HPLC method was developed by using YMC-Triart C8 (250×4.6 mm2) 5m. The mobile phase was used with flow rate is 1.0 mL/min for 40 min run time and 5mL of injection volume. With respect to gradient program, 25 °C column oven temperature 265 nm detection wavelengths, respectively. An analyte is well resolved and selective in view of analytical validation.The method is accurate and precise as well as linear in the range of LOQ to 200 % level with respect to limit concentration of sulphonamide hydrochloride and observed correlation coefficient is 0.999. Recovery at each level for all known impurities were found in range between 85 and 115 %. The method is sensitive and rapid; also accomplish all the criteria of stability, as well as robustness. The propose method would be useful for rapid screening, control impurity and routine analysis of quantitative determination of 4-amino benzene sulphonamide in sulphonamide hydrochloride. HIGHLIGHTS The developed method for sulphonamide hydrochloride is rapid and sensitive also fulfill the criteria for stability and robustness This method useful for rapid screening, control impurity and routine analysis of quantitative determination of 4-amino benzene sulphonamide in sulphonamide hydrochloride This method is also used to determine the concentration of impurity The method is accurate and exact as well as linear, and the observed correlation coefficient is 0.999 GRAPHICAL ABSTRACT
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