STRESS DEGRADATION STUDIES AND DEVELOPMENT OF VALIDATED STABILITY INDICATING METHOD FOR ASSAY OF DONEPEZIL

Abstract

his study describes the development and validation of stability indicating RP-HPLC method for Donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. In order to investigate the stability of drug, a stress testing of drug sample by exposing it to variety of forced degradation conditions has been recommended. Donepezil was subjected to stress degradation under different conditions recommended by International conference on Harmonization (ICH). The ICH guideline gives parameters to be considered when validating methods, the objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. The sample so generated was used to develop a stability indicating High Performance liquid Chromatographic method for Donepezil. The chromatographic separation of Donepezil and its degradation products was done on C18 column. The mobile phase consist of Potassium di Hydrogen Phosphate buffer and Acetonitrile in the ratio 70 : 30. Detection was carried out using single wavelength detector at 230nm. The retention time under optimized chromatographic condition was found to be 8.33 minutes, with asymmetry of 1.11. A good linear response was observed in the range of 2-10 ug/ml. The method showed good recoveries (average 100.15%). The method was validated for specificity and robustness also.