Determination of four dry cough medications in fixed dose form by developed stability indicating liquid chromatography-photodiode array detection

Abstract

This study deals with the development of HPLC assay method for the determination of guaifenesin (GUF), bromhexine (BRH), chlorpheniramine (CHP), and dextromethorphan (DEE) in bulk and Leekuf tablets. Column C18 Aligent eclipse was used to analyse GUF, BRH, CHP and DEE. The H3PO4 (0.01%) and methanol combined in 70:50 (vol/vol) parts was used as mobile phase. The HPLC assay method was validated in accordance with the ICH prerequisite and was capable of providing accurate (99.90% recovery for BRH, 99.40% recovery for CHP, 100.00% recovery for GUF and 99.50% for DEE) and precise (0.160–0.805% RSD range for GUF, BRH, CHP and DEE) quantitative results under slight variations in chromatographic circumstances in the range of quantities 25–150 μg mL−1 (GUF), 2–12 μg mL−1 (BRH), 0.5–3 μg mL−1 (CHP) and 2.5–15 μg mL−1 (DEE). These results concluded that HPLC assay method developed was beneficial for the evaluation of GUF, BRH, CHP and DEE simultaneously in commercial tablet dose. The degradants eluted are well resolved from the GUF, BRH, CHP, and DEE peaks, showing that the process is stability indicating.