Simultaneous estimation of paracetamol in extemporaneous quaternary mixture with Tramadol, Metoclopramide and Domperidone by Rp-HPLC method

Abstract

Some drug combinations, also known as multi-component formulations, have shown promising results due to their combined mechanism of action in the body, which consists of a mixture of medications (paracetamol, tramadol, metoclopramide, and domperidone). In addition to providing greater therapeutic efficacy due to their cumulative or synergistic effects, these drug combinations are also characterized by their lower production cost and the possibility of administering them in a single dose. The aim of this work is to develop novel, simple, accurate, and selective chromatographic methods (reversed-phase high-performance liquid chromatography) for the determination/quantification of these drugs. These methods can be used as analytical tools in routine analyses in quality control laboratories. In this study, RP-HPLC method was used, where the separation was performed on an ULTISIL L10 column (250 mm × 4.6 mm, 5 µm) using a mobile phase composed of a buffer solution and acetonitrile in a ratio of (80:20, v/v) at a flow rate of 1.5 mL min −1 . Detection was performed at a wavelength of 283 nm. In the proposed RP-HPLC method, the peaks were sharp and well separated, with retention times of 2.11, 4.37, 5.72, and 8.77 min, respectively, for paracetamol (PARA), tramadol (TRA), metoclopramide (METO), and domperidone (DMO). Linearity was obtained within the concentration ranges of 25–150, 10–60, 10–30, and 10–30 μg mL −1 , respectively, for paracetamol, tramadol, metoclopramide, and domperidone. The method was validated according to ICH guidelines for linearity, accuracy, precision, selectivity and robustness. This improved method is used to identify drugs in lab-mixtures containing a combination of four drugs. This method is simple and accurate and can be used for routine drug analysis in compounded dosage forms in quality control laboratories.