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Simultaneous assessment of atorvastatin-ezetimibe combination in tablets by an ion-pair rp-hplc Trefi Saleh* Pharmaceutical Quality and Pharmaceutical Chemistry Department, University of Aleppo, Syria *Corresponding Author E-mail: salehtrefi@yahoo.com
Online published on 16 September, 2020. Abstract The purpose of this work was to develop and validate a new ion-pair reversed phase high performance liquid chromatographic method on a standard C18-type stationary phase with UV detection, for the analysis of the two antihyperlipidemic agents as a combination in tablets atorvastatin-ezetimibe. The mobile phase consisted of a 35% of cetyltrimethylammonium bromide (cetrimide) 10−3 M as the ion-pairing agent and 65% acetonitrile. The pH value of the mobile phase was adjusted if necessarily by ammonia solution at 10. The flow rate was 1.5 mL/min and the separation was performed at 40°. The method validation was based on linearity, accuracy, precision and specificity. This method exhibited good linearity and accuracy with mean recovery values between 95–105%, precision with relative standard deviations of the calculated concentrations less than 2% and specificity in the presence of excipients. These results indicates that the proposed method is applicable for the separation and determination of atorvastatin-ezetimibe combination in tablets and could be a relevant method to utilize in quality control laboratories. Top Keywords Ion-pair RP-HPLC, Atorvastatin, Ezetimibe. Top | |
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