Open AccessValidated RP-HPLC Method for Simultaneous Estimation of Domperidone and Naproxen in Bulk Drug and Formulations
Publication year - 2020
Publication title -
international journal for innovative engineering and management research
Language(s) - English
Resource type - Journals
ISSN - 2456-5083
DOI - 10.48047/ijiemr/v09/i12/116
Subject(s) - domperidone , naproxen , chromatography , dosage form , correlation coefficient , chemistry , retention time , high performance liquid chromatography , mathematics , medicine , statistics , alternative medicine , pathology , dopamine , endocrinology
A new , precise , accurate and reproducible RP – HPLC method for simultaneousestimation of bulk and pharmaceutical formulations . Separation of Naproxen and Domperidone wassuccessfully achieved. THERMO HYPERSIL , C 18 , 250mm X 4.6mm , 5μm , or equivalent in anisocratic mode utilizing Acetonitrile : Methanol : Water (20: 60:20 ) at a flow rate of 1.0 mL/ minand elute was monitored at 284nm , with a retention time of 2.341 and 5.225 minutes for Naproxenand Domperidone respectively. The method was validated and the response was found to be linear inthe drug concentration range of 1μg /mL to 6μg/mL. The values of correlation coefficient was foundto be 0.988 for Naproxen and 0.998 for Domperidone respectively. The LOD and LOQ for Naproxenwas found to be 0.56, 1.71 respectively . The LOD and LOQ for Domperidone was found to be 1.49 ,4.5 respectively. This method was found to be good percentage recovery for Naproxen andDomperidone were found to be 98% and 101.6% respectively indicates that the proposed methodwas highly accurate. The specificity of method shows good correlation between retention times ofstandard with the sample. The method was extensively validated according to ICH guidelines forLinearity , Accuracy , Precision , Specificity , and Robustness .