Abstract

Development and validation of stability indicatingHPLCmethod for ezetimibe and atorvastatin calciumin pharmaceutical dosage form

Author(s): Sneha J.Joshi, Suvarna I.Bhoir, Pradnya A.Karbhari, K.S.Bindu

A sensitive, selective, precise and stability indicating method of Ezetimibe and Atorvastatin Calcium in pharmaceutical dosage form was developed and validated. Reverse phase isocratic -HPLC with scanning by photodiode array detection technique was used to analyze samples formed during stress testing and to determine the peak purity of active. The separation was achieved on a Hypersil BDS C18 column, 150mm 4.6mm, 5musing mobile phase 400ml ofMeCNwith 600ml of 0.1Mbuffer at a flowrate of 1.0 mLmin-1. The columnwasmaintained at 400C and detectionwavelength set to 240 nm. The injection volume was 20L. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9989 (for Ezetimibe) and 0.9997 (forAtorvastatinCalcium) in the concentration range of 10 to 200g mL-1. The method was validated in terms of accuracy, precision, and linearity, limit of detection and quantitation and robustness. This method has been successively applied to pharmaceutical formulation and no interference from the tablet excipients was found. Ezetimibe and Atorvastatin Calcium their combination drug product were exposed to acid, base and neutral hydrolysis, oxidation, dry heat and photolytic stress conditions and the stressed samples were analyzed by the proposed method. All the peaks of degraded product were resolved from the standard drug with significantly high resolution. This indicates that the method is reproducible and selective for the estimation of the said drug and can be used as stability-indicating method.