Preliminary Quality Evaluation of New Generic Brands of Ciprofloxacin Tablets

Abstract

Routine quality assessment is essential to ensure safety, efficacy, and compliance with pharmacopeial standards. This study evaluated six newly marketed generic brands of ciprofloxacin 500 mg tablets using in-vitro quality control tests.

In-vitro quality control tests including weight uniformity, thickness, hardness, friability, and disintegration were performed in accordance with the British Pharmacopoeia standards. The ciprofloxacin content was determined using ultraviolet (UV) spectrophotometry (USP Monograph). All brands exhibited uniform white color, consistent shape, and intact markings with no evidence of breakage. Weight uniformity testing confirmed compliance with United States Pharmacopeia (USP) limits, although mean weight differences across brands were statistically significant (p = 0.0001). Tablet thickness showed minimal deviation (SD = 0.03–0.26) but significant inter-brand variation (p = 0.001). Hardness values fell within the 40–100 N range for all except Brand D; ANOVA revealed significant differences between brands (p = 0.001). Friability was below the USP threshold of 1% for all brands, with Brands E and F recording 0.00%. All brands completely disintegrated within 30 minutes, indicating acceptable in-vitro performance. Drug content assay showed that Brands B (103.6%), D (102.1%), E (99.9%), and F (101%) complied with USP specifications (90–110%), while Brands A (77.4%) and C (89.3%) failed.

In conclusion, most evaluated generics demonstrated satisfactory pharmaceutical quality; however, the failure of two brands in drug content assay underscores the need for routine post-market surveillance to safeguard therapeutic equivalence of ciprofloxacin tablets.