Abstract

Improper storage conditions can affect the  pharmaceutical quality and stability of medicines.

Objective: 

This study evaluated the in vitropharmaceutical quality and stability of furosemide tablets under two different storage conditions. 

Method: 

Two generic and one branded furosemide 40 mg tablet formulations were collected from Karapitiya healthcare facilities. Samples were stored for 30 days in the same packaging material as dispensed. A time zero analysis (T0) and stability analysis after one month (T1) were carried out following BP/IP guidelines. Both recommended (T1R) and home (T1H) storage conditions were used to test the stability. T1R mimicked the manufacturer's recommendation (20-25 °C, RH 57%-65%) while T1H mimicked the environmental conditions in a tropical room (27-46 °C, RH 33%-88%). 

Results: 

All samples tested at T0 and T1R complied with official limits of quality parameters except the hardness test (<40 N). At T1H analysis, all samples met the acceptance limits for weight variation (<7.5%), and disintegration (<15 min) tests except hardness (<40 N), friability (>1%), and assay (<95%). Only under home storage conditions, generic samples in polythene packages showed discoloration. 

Conclusion: 

Furosemide tablets stored under recommended storage conditions were within the defined quality specifications and remained stable for 30 days. However,  home storage conditions can negatively impact the drugs’ stability.