Abstract

Treating Helicobacter pylori (H. pylori) infection is challenging for the doctor due to the peculiar pathophysiology of bacteria that leads to antibiotic resistance. Pharmacosome is a novel formulation that could be a promise in treating the infection because of its ability to improve the bioavailability of antibiotics. The objective of this study is to develop and validate an high performance liquid chromatography (HPLC) -based analytical technique to evaluate the stability, % entrapment efficiency (% EE), and the drug release of amoxicillin (AMX) and metronidazole (MEZ) co-loaded pharmacosomes. To illustrate the effect of this method clearly, the design of the experiment tool was used to model the HPLC method. The independent variables were buffer ratio, pH, flow rate, and injection volume. The responses were retention time, drug peak area, and resolution between the drugs. The optimized method was validated as per ICH Q2(R2) guidelines. The linearity was plotted in the 0.5–20 μg/ml range for both AMX and MEZ. The linear regression equation showed an R2 of more than 0.999, proving the linearity of the method. The method was used to check the stability, % EE, and % drug release of antibiotics in the pharmacosomes. The developed method’s accuracy was between 99%–102% for both AMX and MEZ. The inter-day and intra-day precision of the developed method was within the limit for both AMX and MEZ, the %CV was less than 2%. The HPLC method was selective, sensitive, linear, and eco-friendly, with an Analytical GREEnness Metric Approach and Software score of 0.66.

Key words: Helicobacter pylori, amoxicillin, metronidazole, HPLC, design of expert, pharmacosomes, modelling