Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics

This study investigated the quality of various antibiotic preparations (ciprofloxacin hydrochloride, amoxicillin trihydrate, and amoxicillin trihydrate-clavulanate potassium) available in Lebanon, comparing branded and generic versions. The primary objective was to quantify the active pharmaceutical ingredients (APIs) in these medications to determine if they met the United States Pharmacopeia (USP) assay limits, thereby identifying substandard drugs. The research employed ultra-high pressure liquid chromatography (UHPLC) as the analytical method for API content determination. The findings revealed significant quality issues, particularly with ciprofloxacin, where all five tested medications (one brand, four generics) fell outside the acceptable 2% USP range, indicating they were substandard. For amoxicillin, all three tested generics were within the 20% range. In the case of amoxicillin-clavulanic acid, four out of five medications met the 30% clavulanic acid range, with one exceeding the claimed amount, while all five met the amoxicillin assay limit. These results highlight a critical concern regarding the quality and therapeutic equivalence of antibiotics in the Lebanese market, suggesting a potential link to antibiotic resistance due to inconsistent dosing. The study underscores the necessity for robust quality control mechanisms and scientific evidence to support generic drug substitution in developing countries.

This study investigated the quality of various antibiotic preparations (ciprofloxacin hydrochloride, amoxicillin trihydrate, and amoxicillin trihydrate-clavulanate potassium) available in Lebanon, comparing branded and generic versions. The primary objective was to quantify the active pharmaceutical ingredients (APIs) in these medications to determine if they met the United States Pharmacopeia (USP) assay limits, thereby identifying substandard drugs. The research employed ultra-high pressure liquid chromatography (UHPLC) as the analytical method for API content determination. The findings revealed significant quality issues, particularly with ciprofloxacin, where all five tested medications (one brand, four generics) fell outside the acceptable 2% USP range, indicating they were substandard. For amoxicillin, all three tested generics were within the 20% range. In the case of amoxicillin-clavulanic acid, four out of five medications met the 30% clavulanic acid range, with one exceeding the claimed amount, while all five met the amoxicillin assay limit. These results highlight a critical concern regarding the quality and therapeutic equivalence of antibiotics in the Lebanese market, suggesting a potential link to antibiotic resistance due to inconsistent dosing. The study underscores the necessity for robust quality control mechanisms and scientific evidence to support generic drug substitution in developing countries. Research Background and Significance Antibiotic quality assurance is a critical public health issue, especially in developing countries where regulatory oversight may be limited. In Lebanon, concerns have been raised regarding the quality and efficacy of both branded and generic antibiotics available in the market. Poor-quality antibiotics not only comprom