Abstract

PHARMACEUTICAL QUALITY EVALUATION OF CIPROFLOXACIN HYDROCHLORIDE TABLETS AVAILABLE IN DRUG MARKET OF PALESTINE

Nahed Hegazy*, Kholoud Abu Shaaban, Ibrahim El-Bassyouni and Elham Abuwked

ABSTRACT

Purpose: Ciprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. It is widely used antibiotic in Palestine. The objective of this Post-Marketing Pharmaceutical Quality Evaluation of Ciprofloxacin hydrochloride 500 mg tablets to evaluate the quality standards of nine different marketed brands with various price ranges, collected from retail drug stores of Gaza-strip, Palestine. As well, use and validate an analytical method which will be easy to handle, accurate, simple and inexpensive for assay of content of ciprofloxacin hydrochloride in the tablets. Method: The quality of ciprofloxacin tablets was assessed through evaluation of identification using iron (III), uniformity of weight, disintegration, dissolution and assay of content of active ingredient using spectrophotometric method. Results: All brands of ciprofloxacin hydrochloride tablets passed the identification test by using iron (III) through comparing the resulted color from brands with the color which resulted from the pure active substance. Also all brands of ciprofloxacin hydrochloride tablets passed British Pharmacopoeia 2018 standards for uniformity of weight and disintegration tests, and passed United States Pharmacopoeia 41 standard for dissolution test except one brand of ciprofloxacin hydrochloride tablets failed the dissolution test. Six of nine brands of ciprofloxacin hydrochloride tablets do not comply with British Pharmacopoeia 2018 standard for assay of content of active ingredient. Conclusion: only three of nine brands of ciprofloxacin hydrochloride tablets meet quality specifications in Pharmacopoeia. Reaction of ciprofloxacin hydrochloride with iron (III) is sensitive, selective, simple, efficient, inexpensive, and rapid for identification, also the spectrophotometric method used in assay of content of active ingredient of ciprofloxacin hydrochloride tablets is simple, inexpensive, easy to use and could be used in routine monitoring especially in the absence of high technology equipment. In general this study shows the needing for more market monitoring of all available brands of all drugs on the Palestinian drug market.

Keywords: Ciprofloxacin hydrochloride, Pharmaceutical Quality Evaluation, Dissolution Test, Palestine, Pharmacopoeial specifications.