In vitro quality evaluation of leading brands of ciprofloxacin tablets available in Bangladesh

Abstract

Background: Ciprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. The study was carried out to examine the in vitro quality control tests for ten leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Bangladesh by Directorate General of Drug Administration. The quality control parameters of ten different brands of ciprofloxacin hydrochloride 500 mg tablets were determined by weight variation, friability, hardness, disintegration, dissolution and assay tests. All the tablets were evaluated for conformity with United States Pharmacopoeia-National Formulary (USP-NF) and British Pharmacopoeia (BP) standards.

Results: Among ten brands of tablets Brand C had lower mean weight variation of 1.59% and Brand E had highest mean weight variation of 3.32%. For friability test Brand F had lowest mean friability (0.27%) and Brand G had highest mean friability (0.54%). Among ten brands mean lowest and highest hardness were founded in Brand G (4.49 kg/cm²) and Brand F (7.13 kg/cm²) respectively. The disintegration time for ten brands of ciprofloxacin tablet obtained were in the subsequent order: Brand G (8.19 min) < Brand C (9.25 min) < Brand E (9.61 min) < Brand D (10.11 min) < Brand B (11.07 min) < Brand A (12.15 min) < Brand H (13.68 min) < Brand I (14.59 min) < Brand J (16.32 min) < Brand F (17.49 min). Among ten brands for dissolution test mean percentages of drug release were not less than 80% in 45 min for four tablets (Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%), consequently they met BP standard and as per USP-NF standard six brands (Brand B, 75.62%; Brand A, 76.18%; Brand E, 81.52%; Brand D, 86.44%; Brand G, 86.82% and Brand C, 94.12%) had released not less than 75% drugs, so they also complied with the standard. The percentages of the drug content of the ten brands of ciprofloxacin tablet were obtained in the following sequence: Brand H (96.84%) < Brand J (97.34%) < Brand D (98.15%) < Brand I (98.47%) < Brand E (99.37%) < Brand F (100.28%) < Brand B (100.38%) < Brand A (100.54%) < Brand G (101.39%) < Brand C (101.46%). All of the brands met the BP and USP-NF specifications for assay. First-order, Higuchi and Korsmeyer-Peppas kinetics model fit for all of the mentioned ten brands.

Conclusion: The present study revealed that all of the leading brands of this tablet met the quality control parameters as per pharmacopoeial specifications except dissolution test for four brands (Brand J, Brand H, Brand I, and Brand F).

Keywords: Ciprofloxacin hydrochloride; Leading brands; Pharmacopoeial specifications; Quality control.

Fig. 1

Results of weight variation test of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 20/brand)

Fig. 2

Results of friability test of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 20/brand)

Fig. 3

Results of hardness test of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 10/brand)

Fig. 4

Results of disintegration test of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 6/brand)

Fig. 5

Standard calibration curve for ciprofloxacin hydrochloride

Fig. 6

Results of dissolution profile of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 6/brand)

Fig. 7

Results of drug content of ten leading brands of ciprofloxacin tablets. Results were expressed as mean ± SD (n = 20/brand)