Rp-Hplc Method Development And Validation For Simultaneous Estimation Of Pregabalin And Amitriptyline In Its Api And Pharmaceutical Dosage Form

Abstract

A novel and new high performance liquid chromatographic technique has been developed for the simultaneous estimation of Pregabalin and Amitriptyline in its bulk as well as pharmaceutical dosage form. The separation was carried out by using ODS C18 column coupled with UV detector at 238 nm. A triphasic mobile phase, Acetonitrile:Methanol:Water (pH 4 adjusted by orthophosphoric acid) in the ratio of 25:25:50 was used for the separation. The retention time for Pregabalin and Amitriptyline was found to be 1.19 min. and 4.94 min. respectively. The developed method was validated by using various validation parameters. A linear calibration curve was obtained in the concentration range of 4-40 μg/ml. with the correlation coefficient (r2) value of 0.9982 and 0.9992 for Pregabalin and Amitriptyline respectively. The assay was found to be 99.42% and 99.90% for Pregabalin and Amitriptyline respectively. For the precision, % RSD for Pregabalin and Amitriptyline was found to be 0.5860 and 1.0722 respectively. The % Recovery at the level of 100% was found to be 99.1% for Pregabalin and 99.5% for Amitriptyline. Hence, it can be concluded that the new, simple, linear, precise, accurate, suitable and specific analytical method is developed and validated and can be used for routine analysis of its formulation.