Evaluating the Quality of Ofloxacin in Pharmaceutical Products sold in Vientiane Capital, Laos

Abstract

Ofloxacin is a fluoroquinolone antibiotic widely used for the treatment of bacterial infections, with activity against both gram-negative and gram-positive bacteria. According to the United States Pharmacopeia (USP) standard, the content of ofloxacin in pharmaceutical products must be within 90–110%. The objective of this study was to evaluate the quality of 200 mg ofloxacin tablets available in Vientiane Capital. A total of 10 samples were collected from community pharmacies in Vientiane Capital. The evaluation included weight uniformity, friability, disintegration, dissolution, and assay of ofloxacin content using HPLC. Method validation demonstrated good linearity within the concentration range of 1–100 μg/mL with an R² value of 0.9990. The precision of the method expressed as %RSD was ≤2%, and the accuracy averaged 97.60%. The results showed that one sample did not meet the weight uniformity requirement, two samples failed the disintegration test, and one sample failed the dissolution test. The assay of ofloxacin content in the finished products ranged from 90% to 99.4%. Overall, the analytical method met the required validation standards. However, some samples of ofloxacin 200 mg tablets did not comply with the specified standards for weight uniformity, disintegration, and dissolution.