Packaging and High-Performance Liquid Chromatography Analysis of Amoxicillin Capsules from Nablus, Palestine.

Abstract

The global rise in antibiotic consumption, along with the prevalence of substandard and falsified (SF) antibiotics, raises concerns about the quality of these important medicines. Additionally, the accessibility of antibiotics without a prescription and insufficient regulatory oversight in many lower- to middle-income countries exacerbate the issue. In particular, there is limited published research on antibiotic quality testing in the Middle East, and more specifically in Palestine. In this study, covert shoppers collected 59 samples of amoxicillin capsules with dosages of 500 mg from Nablus, Palestine, during August 2022. None of the pharmacies or clinics visited requested a prescription from the covert shoppers, despite the fact that all the boxes, when boxes were provided, were labeled as prescription-only medicines. Five different brands, representing 15 unique lot numbers, were collected from 31 locations. All capsules were packaged in their original blister packs, with 10.2% of those packs torn and 27.1% of the dosage forms having visible powder outside the capsule. All of the blister packs were clearly labeled with the lot number, expiry date, brand name, active pharmaceutical ingredient name, dosage, and manufacturer. The samples were analyzed using high-performance liquid chromatography according to a modified United States Pharmacopeia method. The results indicated that all samples met the standard of containing 90-120% of the stated dose of amoxicillin, with an average dosage and standard deviation of 488 mg and 25 mg, respectively. This SF rate is much lower than that found in most published studies of antibiotics in the Middle East.