Study of Validation Procedure for Ezetimibe and Simvastatin in its Pure and Pharmaceutical Dosage Form using HPLC and its Behavior in FT-IR

Sanju Srinivas¹, A. Jayalaxmi²
1Associate Professor Department of Pharmacy, Ganga Pharmacy College, Nizamabad, Telangana
2Department of Pharmaceutical Analysis, Ganga Pharmacy College, Nizamabad, Telangana

ABSTRACT
A new method was established for simultaneous estimation of Ezetimibe  and Simvastatin by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Ezetimibe   and Simvastatin by using Thermosil C18 column (4.0×125mm) 5µ , flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate buffer pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. The retention times were found to be 2.566 mins and 3.417 mins. The % purity of Ezetimibe  and Simvastatin was  found  to  be  101.27% and  99.97%  respectively. The  system  suitability parameters  for Ezetimibe  and Simvastatin such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Ezetimibe  and Simvastatin was found in concentration range of 5µ g-25µ g and 50µ g-250µ g and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability  was  0.86  and  0.82,  %  RSD  for  intermediate  precision  was  0.44  and  0.19 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and  5.68, and LOQ value was 0.0172 and 0.2125 respectively. Hence the suggested RP-HPLC 
Keywords: Thermosil C18 column, Ezetimibe and Simvastatin, RP-HPLC