RP-HPLC Method Development and Validation of Paracetamol, Ambroxol, Hydrochloride Levocetirizine Dihydrochloride Pseudoephedrine Hydrochloride in Bulk and in Formulation

A simple, exact, and reliable reverse phase liquid chromatographic technique was developed for the simultaneous detection of paracetamol, ambroxol hydrochloride, levocetirizine dihydrochloride, and pseudoephedrine hydrochloride in tablet dosage forms. The analysis was carried out using C18 (150 mm x 4.6 mm i.d.) and a mobile phase with an acetonitrile : water (pH6 adjusted with orthophosphoric acid) ratio of (60:40). The detection employed a flow rate of 1.0 ml/min and a wavelength of 257 nm. Levocetirizine dihydrochloride, pseudoephedrine hydrochloride, ambroxol hydrochloride, and paracetamol all had retention periods that were, respectively, 2.396 minutes, 4.829 minutes, 2.807 minutes, and 3.620 minutes. According to ICH recommendations, the method was authorized. The approach's specificity, precision, linearity, accuracy, and robustness were all confirmed. For paracetamol, ambroxol hydrochloride, levocetirizine dihydrochloride, and pseudoephedrine hydrochloride, the linearity ranged from 4 to 24 g/ml.The proposed method was successfully used to measure paracetamol, ambroxol hydrochloride, levocetirizine dihydrochloride, and pseudoephedrine hydrochloride in combination tablet formulation