Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria.

Abstract

Background: Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions.

Objective: This research surveyed the quality fitness of some ciprofloxacin and metronidazole infusion samples marketed in South-eastern of Nigeria.

Methods: Using Official Compendial methods, microbiological quality, active pharmaceutical ingredients quantitation, pH and particle count tests were evaluated on eighty infusion bottles (from eight pharmaceutical companies) of each of the two drugs.

Results: Out of the sixteen brands tested, 2 metronidazole brands and 1 ciprofloxacin brand (representing 18.75% of the total 16 brands/makes) were contaminated while the remaining 13 brands (81.25%) were found sterile. The active pharmaceutical ingredients quantitative assay showed that all the brands of ciprofloxacin infusion were between the 95% and 105% limit of label claim while one metronidazole brand has <95-110% limit label claim. Six brands each of the two drugs evaluated fall below the acceptable pH range [ciprofloxacin (3.5-4.6) and metronidazole (4.8-5.2)], while the other two brands of both drugs passed the test. In the antibacterial study, Pseudomonas aeruginosa and Escherichia coli were susceptible to the ciprofloxacin (5 µg). However, Salmonella typhi recorded inhibition zone diameters within resistant and intermediate range. Peptostrepococcus spp was susceptible (at minimum inhibitory concentrations of 100 µg/mL) to all the brands of metronidazole, while none of the brands were effective on Lactobacillus spp. All the brands passed the test for particulate contamination. The particles size range was <10µm.

Conclusion: About eighty-one percent (81.25%) of the infusions have acceptable good microbiological quality. However, 18.75% that failed the tests is a concern knowing that these are lifesaving products.