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 The samples were withdrawn from the climatic chamber and analyzed periodically (0,1,2,3,6 months) by an HPLC method with UV detection.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 The samples were withdrawn from the climatic chamber and analyzed periodically (0,3,6,9,12,18,24,36 months) by the previous method mentioned above.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 101
- Downloads 0
INCIDENCE, PREVENTION AND MANAGEMENT OF CATHETER ASSOCIATED URINARY TRACT INFECTION
Catheter associated urinary tract infection attributed to the use of an indwelling urinary catheter is one of the most common infection acquired by patients in health care facilities. As biofilm ultimately developed on a...
PREVENTATION AND MANAGEMENT OF DIABETES THROUGH AYURVEDA IN CONTEXT OF MODERN LIFE STYLE
Diabetes Mellitus is defined and clinical syndrome characterised by the raised sugar level in the blood due to impaired metabolism of the carbohydrates, proteins & fat. DM is presently pandemic with increased morbidity a...
MODULATORY EFFECTS OF LNM ON LYMPHOCYTIC APOPTOTIC PATHWAY THROUGH P53, BCL2,
By using immunocytochemistry technique the apoptotic activity of Leinamycin against lymphocytes isolated from Acute Lymphocytic Leukemia patients in comparison with healthy individuals was determined by measuring P53 and...
CELL WITH A GIANT NAME:-GIANT CELL LESION OF THE ORAL CAVITY-AN UPDATE
Diagnosis of many lesions of the oral cavity is challenging to most clinicians because of their uncommon prevalence. A number of cystic, metabolic, osteodystrophic, microbial, tumour and tumour like lesions of the oral c...
TARGETING OF ANTI CANCER DRUGS THROUGH NANOPARTICLES
studies suggested that nanoparticle drug delivery might improve the therapeutic response to anticancer drugs and allow the simultaneous monitoring of drug uptake by tumours. Cancer Nano therapeutics are rapidly progressi...