Abstract

STABILITY STUDY OF ESOMEPRAZOLE PREPARATIONS IN DIFFERENT PACKAGING MATERIAL USING STABILITY INDICATING VALIDATED HPLC METHOD

Issa Al-Salloum* and Bashar Al-Sabti

ABSTRACT

A stability study of esomeprazole was carried out in accordance with the guideline for Industry Q1A(R2): Stability Testing of New Drug Substances and Products.[1] Esomeprazole is sensitive to heat, humidity, and light, consequently, accelerated tests for stability evaluation were performed at 40°C±2°C 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. The samples were withdrawn from the climatic chamber and analyzed periodically (0,1,2,3,6 months) by an HPLC method with UV detection.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. Long-term stability tests were also performed at 25°C±2°C and 60±5% relative humidity (RH), according to the current official guideline. The samples were kept in a climatic chamber for 3 years in the conditions described above. The samples were withdrawn from the climatic chamber and analyzed periodically (0,3,6,9,12,18,24,36 months) by the previous method mentioned above. The purpose of this study was to select the best packaging and container for esomeprazole products and to use the results obtained in stability testing in order to estimate the expiration date in normal room temperature conditions (25°C±2°C).

Keywords: Stability, accelerated, long-term, Esomeprazole, HPLC.