Comparative in Vitro Quality Evaluation of Ciprofloxacin Tablets collected from local market

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Abstract

Ciprofloxacin is a versatile antibiotic that fights a wide range of bacteria, both Gram-negative and Gram-positive. This study looked at the quality and consistency of several 500 mg ciprofloxacin tablet brands available in local pharmacies in Tigray. To check weight uniformity, we weighed twenty tablets from each brand. We tested how quickly the tablets break down in water at a temperature of 37 ± 0.5°C. We also ran dissolution tests using a paddle apparatus, measuring how much of the drug dissolved at 276 nm. For the active ingredient analysis, we used High-Pressure Liquid Chromatography (HPLC) with a specific setup: a stainless steel column filled with a special silica gel (Hypersil BDS), UV-VIS detection at 278 nm, a flow rate of 1.5 ml/min, and an oven set at 40°C. The results were impressive. The friability rates (which measure how easily tablets crumble) were between 0.04% and 0.08%, well below the BP standard of less than 1%. The tablets' hardness ranged from 11.45 to 32.43 kgf, meeting the requirement of being above 5 kgf. The tablets disintegrated in 3 to 4.5 minutes, well within the 30-minute limit set by BP and USP-40 standards. Dissolution tests showed that over 80% of the ciprofloxacin was released within 30 minutes, with results between 93.5% and 101.2%. The active ingredient assays, both UV and HPLC, met BP standards. The CP-500 brand had the highest results, with 104.3% by UV and 103.9% by HPLC, all within the acceptable range of 95.0–105.0% (BP) and 90.0–110.0% (USP). Overall, the study confirmed that the ciprofloxacin tablets from different brands in Tigray's local market are of high quality.

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