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

Abstract

BackgroundCiprofloxacin 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.ResultsAmong 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.ConclusionThe 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).

Fighting fake medicines: Quality evaluation of seven brands of Albendazole tablets in Yemeni Market

“…However, five brands (71%) failed to fulfill the quality control standards. These findings are similar to those of previous studies in Rwanda and Bangladesh, which revealed that the existence of substandard formulations at purchase time is due to manufacturers' errors (9,27,22). On the contrary, these findings are not in line with previous studies from Yemen, Rwanda and Tanzania, which did not find substandard formulations at purchase time (12,23).…”

Assessment of Physicochemical Properties and Comparison of Dissolution Profiles of Metformin Hydrochloride Tablets in Saudi Arabia

“…Microsoft Office 2010, Sigma plot 14.0 software, and Excel 2010 were used for determination of the following parameters: area under dissolution curve (AUC), mean dissolution time, dissolution efficiency (DE), difference factor (f 1 ), and similarity factor (f 2 ). The selected generic and innovator products were subjected to weight variation, friability, and hardness tests according to the methods described by the United States Pharmacopeia (10,21).…”

“…drug's share in the global pharmaceutical market is approximately 10%, which is estimated to be increased to 25% in developing countries and may increase to 50% in certain poor countries. The FDA has reported that in poor countries, approximately 25% of drugs available for the consumers are either substandard or counterfeit drugs (10). Moreover, according to WHO, the annual trade from fake medicines are about 73 billion Euros (13).…”

“…Generic drugs are significantly useful to decrease the cost of healthcare; however, sometimes the quality of medication has been compromised, mainly in products manufactured in poor and developing counties. There are certain cases of identification of counterfeit and substandard drugs, where the quality of these products does not meet the pharmaceutical standards; as a result, such products may be ineffective or even harmful for the consumers (10,11). Counterfeit drugs may be a drug product with inadequate or without active ingredient, wrong ingredients, and correct active ingredient with fake packaging (12).…”

Quality Control Tests for Ophthalmic Pharmaceuticals: Pharmacopoeial Standards and Specifications

“…Quality is sustainability of drugs for their desired use measured by their efficiency, safety, consistent with label claim, or endorsed their conformity to specifications concerning identity, strength, purity and other characteristics [8]. According to International Organization for Standardization, quality control (QC) is the operational techniques and activities that are used to fulfill requirements for quality [9].…”