Tuesday , 16 April 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Ezetamibe and Simvastatin by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Y. Krishna Reddy1, Dr. P.M Patel2
1Associate Professor, Bomma Institute of Pharmacy, Khammam, Telangana, India
2Principal, Kalol Institute of Pharmacy, kalol, Gujarat, India

A new method was established for simultaneous estimation of Ezetamibe and Simvastatin by RP-HPLC method.  The chromatographic conditions were successfully developed for the separation of Ezetamibe and Simvastatin by using Agilent C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Methanol: ACN   (70:30%v/v), detection wave length was 238nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2.The retention times were found to be 2.443 mins and 2.918 mins. The % purity of Ezetamibe and Simvastatin was found to be 100.7% and 101.4% respectively. The system suitability parameters for Ezetamibe and Simvastatin such as theoretical plates and tailing factor were found to be 1.7, 2114.5and 1.7, 2931.0 the resolution was found to be 8.0.The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Ezetamibe and Simvastatin was found   in   concentration   range   of   1μg-5μg   and   100μg-500μg   and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 2.0 and 2.0, % RSD for intermediate precision was 1.5 and 1.1 respectively.  The precision study was precise, robust and repeatable. LOD value was 2.95 and 3.04, and LOQ value was 9.87 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Ezetamibe and Simvastatin in API and Pharmaceutical dosage form.
Keywords: Ezetamibe, Simvastatin, HPLC

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