Development and Validation of HPTLC Method for Simultaneous Estimation of Erdosteine, Guaiphenesin and Terbutaline Sulphate Using Box-Behnken Design

Abstract

The present study was aimed to develop and validate a simple, rapid, accurate, precise, and sensitive HPTLC method using DoE approach for the simultaneous estimation of erdosteine, guaiphenesin and terbutaline sulphate in syrup formulations. HPTLC separation was performed on aluminium plates precoated with silica gel 60 F254 as the stationary phase, three different factors like methanol content, chamber saturation time and distance travelled were optimized using Box-Behnken Design Good separation was obtained with toluene:dichloromethane:methanol:glacial acetic acid (4:4:1.81:0.2; % V/V/ V/V) mobile phase. Quantification was achieved by densitometric analysis of erdosteine, guaiphenesin and terbutaline sulphate over the concentration range of 500-3000, 200-1200 and 25-150 ng/band, respectively, at 225 nm. The method was validated for precision, accuracy, robustness, specificity, limit of detection and limit of quantitation as per ICH guideline. The method was successfully applied for the quantitative determination of erdosteine, guaiphenesin and terbutaline sulphate in in-house dosage form, i.e. syrup.