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
Related Articles
- EP ID EP150694
- DOI -
- Views 118
- Downloads 0
COMPARATIVE STUDY OF IN-PROCESS AND FINISHED PRODUCTS QUALITY CONTROL TESTS OF INDIAN PHARMACOPOEIA, BRITISH PHARMACOPOEIA & UNITED STATES PHARMACOPOEIA FOR CAPSULES AND LIQUID ORALS
Present study deals with a brief overview of the comparative study of quality requirements for in-process and finished products quality control Tests of Indian Pharmacopeia (IP), British Pharmacopeia (BP) & United St...
A RETROSPECTIVE STUDY ON THE POTENTIAL DRUG INTERACTION BETWEEN ANGIOTENSIN CONVERTING ENZYME INHIBITOR OR ANGIOTENSIN RECEPTOR ANTAGONIST AND OTHER DRUGS IN END-STAGE CHRONIC RENAL FAILURE PATIENTS
Increasing number of chronic renal failure (CRF) patients had reflected an increase in the number of patients with diabetes and hypertension. Therefore, health practitioners would be faced with management of complicated...
PRELIMINARY PHYTOCHEMICAL ANALYSIS AND ACUTE ORAL TOXICITY STUDY OF MUCUNA PRURIENS LINN. IN ALBINO MICE
Mucuna Pruriens Linn. is an annual, climbing shrub which has an important place among aphrodisiac herbs in India since the ancient times. The plant has been using traditionally for many medicinal purposes such as Inferti...
SYNTHESIS AND EVALUATION OF OXAZOLIDINONES HAVING BENZO THIAZINEN MOIETIES AS ANTIMICROBIAL AND ANTI-INFLAMMATORY AGENTS
Phenyl oxazolidinones were prepared from R-glycidyl butarate and Para bromo aniline, further (3-(4-bromophenyl) methylene oxazolidine-5yl) and substituted benzothiazinen was refluxed resulted in oxazolidinones benzothiaz...
DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF OLEANOLIC ACID IN ARISTAKA
A Simple, monetary, reproducible, precise High performance thin layer chromatography (HPTLC) method was used to determine the content of Oleanolic acid in methanolic extract of Sapindus trifoliatus Linn. using Toluene: E...