STABILITY STUDY OF OMEPRAZOLE.
CRISTINA IUGA*, MARIUS BOJIŢĂ
“Iuliu Haţieganu” University of Medicine and Pharmacy, Faculty of
Pharmacy, 400349, str. Louis Pasteur nr.6, Cluj Napoca, Romania
Department of Drugs Analysis
*corresponding author: iugac@umfcluj.ro
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Abstract:

We carried out a stability study of omeprazole in accordance with the stability testing of pharmaceuticals guideline approved by the Romanian National Drug Agency [1].
Omeprazole is sensitive to heat, humidity, light, and organic solvents; consequently, accelerated tests for stability evaluation were performed at 40ºC±2ºC and 75±5% relative humidity (RH), according to the current official guideline. The samples were kept in a climatic chamber for 6 months in the conditions described above. Half of the samples were also exposed to light. The samples were withdrawn from the climatic chamber and analyzed periodically (0; 0.2; 0.4; 2; 4; 5; 6 months) by an HPLC method with UV detection. A standard statistical methodology was used to calculate the expiration date based on the analytical results obtained in the studied samples.
The purpose of this study was to use the results obtained in accelerated stability testing in order to estimate the expiration date in normal room temperature conditions (25ºC±2ºC).

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