Comparative in vitro quality assessment of five brands of furosemide tablets marketed in Port Harcourt, Nigeria

Abstract

Background: Medication failure, high morbidity and mortality resulting from the circulation and consumption of fake, adulterated and substandard medicines have been a worrisome issue to health practitioners, patients and drug regulatory agencies of Nigeria.
Objective: This study aims at evaluating some brands of furosemide tablets that are marketed in Port Harcourt, Nigeria to know if they meet with their label claims and British Pharmacopoeia (BP) or the United States Pharmacopoeia (USP) set limits for such products.
Materials and Methods: Five brands of furosemide tablets marketed in Nigeria were randomly collected from different retail pharmacy outlets and investigated for uniformity of tablet weight, disintegration, friability, hardness, and drug release profile using standard methods. Two assay methods based on titrimetry and spectrophotometry were employed for the determination of the content of furosemide in the tablet formulations or its bulk drug.
Results: Results obtained showed tablet weight in the range of 174 mg ± 0.05% to 274 mg ± 0.01 %, hardness ranging from 3.20 ± 0.01 to 10.70 ± 1.70 kg/F, friability of < 1 %, disintegration time of 5.20 ± 0.88 to 9.30 ± 0.50 min, drug release of > 80 % within 30 min and assay of 86.45 to 100.80 % .
Conclusion: Most of the tablet batches tested met with label claim in terms of the content of furosemide and also complied with acceptance limits of the British Pharmacopoeia (BP) or the United States Pharmacopoeia (USP) and were adjudged to be of good quality.

Keywords: Furosemide, active pharmaceutical ingredient, British Pharmacopoeia, United States Pharmacopoeia.