STABILITY STUDY OF ESOMEPRAZOLE PREPARATIONS IN DIFFERENT PACKAGING MATERIAL USING STABILITY INDICATING VALIDATED HPLC METHOD
Journal Title: WORLD JOURNAL PHARMACY AND PHARMACEUTICAL SCIENCE - Year 2019, Vol 8, Issue 9
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 The samples were withdrawn from the climatic chamber and analyzed periodically (0,1,2,3,6 months) by an HPLC method with UV detection.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 The samples were withdrawn from the climatic chamber and analyzed periodically (0,3,6,9,12,18,24,36 months) by the previous method mentioned above. Also, many samples are put in different conditions of temperature and humilities and analysis after that. 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).
Authors and Affiliations
Issa Al-Salloum
Keywords
Related Articles
- EP ID EP669068
- DOI -
- Views 146
- Downloads 0
MBA DEGREE VERSUS ENTREPRENEURIAL EDUCATION: THE EFFECT OF ACADEMIC QUALIFICATION ON ENTREPRENEURIAL ORIENTATION OF COMMUNITY PHARMACISTS
Entrepreneurs are not born but made through a combination of innate characteristics, traits, education and environment. It is widely believed that education is not a prerequisite to business success. The dearth of data l...
AUTECOLOGY AND INSECTICIDAL POTENTIAL OF MENTHA LONGIFOLIA FROM MADINAH EL MONAWARA
Mentha plants are grown in abundance in Al-Madina. Their potentials in the medicine and aromatic industry are widely studied. Soil physicochemical studies were carried out to determine the best condition for the growth o...
GREEN CHEMISTRY: BEGINNING, RECENT PROGRESS, AND FUTURE CHALLENGES
Throughout a long time, green chemistry (GC) reviled how a basic scientific methodology and advanced practice can enhance the safe output to the human life and the environment without compromising the desired outcomes. F...
ANTIBACTERIAL SCREENING OF AQUEOUS EXTRACTS OF SOME MEDICINAL PLANT AND THEIR FRACTIONS USED AS ANTIDIARRHEAL AGENTS IN KINSHASA-DEMOCRATIC REPUBLIC OF CONGO
Thirteen aqueous extracts (decoctions) used as antidiarrheal in Kinshasa, Democratic Republic of Congo and their forty two fractions were submitted to an evaluation for their potential antibacterial properties against is...
EFFICACY AND SAFETY OF LEVETIRACETAM AS MONO AND ADD ON THERAPY IN TREATMENT OF EPILEPSY
Background: Epilepsy is the second most common chronic neurological disorder after migraine affecting 2% of population with a high incidence of failure to achieve seizure freedom with the usual antiepileptic drugs. Levet...