Spectroscopic In-Vitro Drug-Drug Interaction Studies of Amoxicillin and Paracetamol Solid Dosage Forms

Abstract

Potential drug-drug interactions (DDIs) are a public health concern in clinical therapy and drug development because of their contribution to actual adverse drug reactions (ADRs) or events. The study aimed to quantify the in-vitro drug-drug interaction of amoxicillin (AMX) and paracetamol (PCM) formulations which are commonly co-administered. Determinations were carried out by spectroscopic methods – zero-order and derivative spectroscopy. The data were analyzed using Microsoft Excel, 2016. The UV-Spectra of AMX and PCM showed two distinctive peaks at 240 nm and 260 nm were observed for AMX, while for PCM at 290nm and 340 nm, with maxima at 240 nm and 340 nm for AMX and PCM respectively. Absorption measurements were taken at the maximum wavelength of 290 nm and 240 nm for PCM and AMX respectively. The content of both drugs and potential DDIs of AMX and PCM were assayed by zero- and 3rd-derivative spectroscopy. The calibration curves for AMX and PCM standards showed good linearity at concentrations, with corresponding correlation coefficients (R) being 0.999 and 0.998. The intercept and slope for AMX were -0.0148 and 0.0732 respectively, while for PCM values were 0.0071 and 0.148. The content of PCM and AMX in the formulations was 98.40 ± 0.44% and 96.04 ± 0.29% respectively. The joint-drug-dissolution studies for AMX and PCM interaction (DDI) were obtained with the 3rd-order derivative spectroscopy at 210 nm (zero-crossing for PCM) and 290 nm (zero-line crossing for AMX) respectively - which showed overlapping spectra for their zero-order derivative spectra. No significant difference was observed in the in-vitro drug release profiles for AMX and PCM, while comparative profiles were observed to have a very strong correlation between individual-release and joint-release profiles.