Stability study of losartan/hydrochlorothiazide tablets.
The purpose of stability testing is to investigate how the quality of a drug product changes with time under the influence of environmental factors, to establish a shelf life for the product and to recommend storage conditions. Stability study of losartan/hydrochlorothiazide tablets is presented in this paper. Losartan (angiotensin II receptor antagonist) and hydrochlorothiazide (diuretic) are successfully used in association in the treatment of hypertension. Stability study of losartan/hydrochlorothiazide tablets consisted of three steps: stress test (forced degradation study), preliminary testing (selection of packaging) and formal stability testing. The results of stress test suggested that losartan/hydrochlorothiazide tablets are sensitive to moisture. It was demonstrated that the developed analytical methods are stability indicating. Additional preliminary testing was performed in order to select appropriate packaging for losartan/hydrochlorothiazide tablets. OPA/Al/PVC//Al blisters were found to provide adequate protection for the product. Based on the first 12 months of the formal stability study, a shelf life of 24 months was proposed. Losartan/hydrochlorothiazide tablets in OPA/Al/PVC//Al blisters are demonstrated to be chemically, physically and microbiologically stable.
Lusina
Maja
M
PLIVA-Research Institute Ltd., Analytics, Prilaz baruna Filipovića 29, 10000 Zagreb, Croatia. maja.lusina@pliva.hr
Cindrić
Tanja
T
Tomaić
Jadranka
J
Peko
Marijana
M
Pozaić
Lidija
L
Musulin
Nenad
N
D004338:Drug Combinations; D004340:Drug Contamination; D004349:Drug Packaging / Q000379:methods; D004355:Drug Stability; D006852:Hydrochlorothiazide / Q000032:analysis* / Q000737:chemistry; D019808:Losartan / Q000032:analysis* / Q000737:chemistry; D015394:Molecular Structure; D013607:Tablets; D013997:Time Factors
D004338:Drug Combinations; D013607:Tablets; D006852:Hydrochlorothiazide; D019808:Losartan