Development and Validation of Stability Indicating Reverse Phase High Performance Liquid Chromatographic Method for estimation of Donepezil HCl from bulk drug
Stability of Donepezil Hydrochloride(DONE) was investigated using stability indicating Reverse phase high performance liquid chromatography (RP-HPLC) utilizing C-18 column and mobile phase containing Acetonitrile:Water (pH 3.5)Â in ratio of 40:60 at flow rate of 1 ml min-1. Peaks of donepezil and degradation products were well resolved at retention times < 7 min. Stability was performed in 0.1N hydrochloric acid, 0.1N sodium hydroxide, 3 % hydrogen peroxide, neutral, photolytic and dry heat conditions. Fast hydrolysis was seen in alkaline condition as compared to oxidative and neutral conditions. Methods was validated with respect to linearity, precision, accuracy, specificity and robustness LOQ and LOD. It was also found to be stability indicating, and therefore suitable for the routine analysis of Donepezil hydrochloride in the pharmaceutical formulation.
2. Joe GH, Perry BM and Raymond WR. Goodman Gilmanâ€™s pharmacological basis of therapeutics. 11th Edition, Mcgraw Hill medical publishing, New york, 2001,pp 506.
3. Noppamas R, Siriluk A, Nutthiya H, Sukit R and Supanimit. Bioequivalence Study of Donepezil Hydrochloride Tablets in Healthy Male Volunteers. Int. Scholarly Research Notices. 23(6); 2012: 1-4.
4. Sethi PD and Sethi R . HPLC : Quntitative Analysis of Pharmaceutical Formulation, Published by CBS, 2007; 15 th ed: pp 1-211.
5. International Conference on Harmonization, Harmonized Tripartite Guideline, Validation of Analytical Procedures, Text and methodology, ICH Q2(R1), 2005.
6. International Conference on Harmonization, Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products (Revision 2), ICH Q1A(R2), 2003.