A VALIDATED REVERSE PHASE HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF SIMVASTATIN AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

<!-- /* Font Definitions */ @font-face {font-family:"MS Mincho"; panose-1:2 2 6 9 4 2 5 8 3 4; mso-font-alt:"ＭＳ 明朝"; mso-font-charset:128; mso-generic-font-family:modern; mso-font-pitch:fixed; mso-font-signature:-1610612033 1757936891 16 0 131231 0;} @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:1; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:variable; mso-font-signature:0 0 0 0 0 0;} @font-face {font-family:"\@MS Mincho"; panose-1:2 2 6 9 4 2 5 8 3 4; mso-font-charset:128; mso-generic-font-family:modern; mso-font-pitch:fixed; mso-font-signature:-1610612033 1757936891 16 0 131231 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman","serif"; mso-fareast-font-family:"MS Mincho"; mso-fareast-language:JA;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-size:10.0pt; mso-ansi-font-size:10.0pt; mso-bidi-font-size:10.0pt; mso-fareast-font-family:"MS Mincho";} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.0in 1.0in 1.0in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.Section1 {page:Section1;} -->

A simple, sensitive and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Simvastatin and Ezetimibe in pharmaceutical dosage forms. The mobile phase consisted of Acetonitrile: buffer (0.1% v/v ortho phosphoric acid, PH – 3) in the ratio of 75:25 v/v delivered at a flow rate of 1.5 ml / min and wavelength of detection at 238nm. The retention times of Simvastatin and Ezetimibe were 7.0 min and 2.4 min respectively. The developed method was validated according to ICH guidelines. The proposed method can be used for determination of these drugs in combined dosage forms.