Stability indicating RP-HPLC method for simultaneous determination of guaifenesin and pseudoephedrine hydrochloride in the presence of syrup excepients

Abstract

The present work concerns with the development of stability indicating the RP-HPLC method for simultaneous determination of guaifenesin (GUF) and pseudoephedrine hydrochloride (PSH) in the presence of guaifenesin related substance (Guaiacol). GUC, and in the presence of syrup excepients with minimum sample pre-treatment. In the developed RP-HPLC method efficient chromatographic separation was achieved for GUF, PSH, GUC and syrup excepients using ODS column as a stationary phase and methanol: water (50:50, v/v, pH=4 with orthophosphoric acid) as a mobile phase with a flow rate of 1mLmin−1 and UV detection at 210nm. The chromatographic run time was approximately 10min. Calibration curves were drawn relating the integrated area under peak to the corresponding concentrations of PSH, GUF and GUC in the range of 1–8, 1–20, 0.4–8μgmL−1, respectively. The developed method has been validated and met the requirements delineated by ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness. The validated method was successfully applied for determination of the studied drugs in triaminic chest congestion® syrup; moreover its results were statistically compared with those obtained by the official method and no significant difference was found between them.