DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND ENALAPRIL MALEATE
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 8
Abstract
Stability testing is a routine procedure performed on drug substances and drug products to provide evidence on how the quality of a drug varies with time under the influence of a variety of parameters. Environmental factors such as temperature, humidity and light can potentially affect product quality and requires establishing a re-test period for the drug substance or a shelf-life for the drug product and recommended storage conditions. Companies rely on the stability data to establish an expiry for marketed pharmaceutical products. To investigate potential stability issues of the drug in AMECA tablet, accelerated and intermediated stability studies were carried out according to ICH guidelines at 300C+20C/65%RH+ 5%RH and 400C+20C/75%RH+5%RH for six month. Stability studies were carried out using programmable environmental test chamber CHM-10s, serial no. ICH-2530 and ICH 2531 (Remi instrument Ltd, Mumbai) and assay was carried out by using HPLC (Jasco) method which has been developed previously. The stability testing of AMECA tablets showed there was no significance change in the content of Amlodipine Besylate and Enalapril Maleate after 6 month of storage under controlled of temperature and humidity, at 300C+20C/65%RH+5%RH. Accelerated conditions under 400C+20C/75%RH+5%RH, dosage forms exhibit slight but insignificant fall within assay value. The parameters such as appearance, hardness, friability, disintegration time periods were determine at regular interval of each month for total period of six months. It showed that there was no change in physical parameter for six months at stored condition.
Authors and Affiliations
Ashpak Tamboli , Naziya Khan , Javed Manure , Sohrab Shaikh , Shrinivas Mohite
Keywords
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