PHARMACEUTICAL QUALITY AND STABILITY OF FUROSEMIDE TABLETS IN TROPICAL STORAGE CONDITIONS: AN IN-VIT

2023-04-18 2023-06-17 2023-06-29 3/26/2025 10:48:19 PM Journal of Applied Pharmacy 15 2023 Original research article 31 40 2023 19204159.15.31 https://dx.doi.org/10.21065/19204159.15.31 English Anuruddhika K.P.I.I.*, Jayasinghe, M. Subasinghe H.W.A.S, Wijesekera K. Furosemide; Medicine stability; Post-market surveillance; Quality control; Sri Lanka; Storage conditions. 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.