COST EFFECTIVE STABILITY INDICATING RAPID, EFFICIENT ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RELATED SUBSTANCES METHOD FOR SIMULTANEOUS DETERMINATION OF SIMVASTATIN AND EZETIMIBE IN TABLET FORMULATIONS

Neelu Jain, Srinivasarao Kosanam*, Surendra Singh Rao, Asheesh Singh

Sri Satya Sai University of Technology & Medical Sciences, Sehore, Madhya Pradesh, India

ABSTRACT

An efficient, cost effective, rapid reverse phase high-performance liquid chromatographic method was developed and validated for the determination of Ezetimibe and Simvastatin in pharmaceutical dosage forms. Chromatography was carried out by using X-terra C18, 150 x 4.6mm, 3.5μ or equivalent internal diameter with a mixture of 0.5 mL glacial acetic acid in 2000 mL water as mobile phase A and Acetonitrile as mobile phase B. Analytical method validation parameters such as specificity, linearity, precision, accuracy, solution stability and robustness, limit of detection (LOD) and limit of quantification (LOQ) was done. The correlation coefficient was found to be linear for each analyte in the desired concentration range. The average recovery was found with range of 96.7 and 107.7 for Ezetimibe and Simvastatin and their respective impurities respectively. The proposed method is highly sensitive, precise and accurate, which was evident from the LOD value range of minimum 0.135 ppm for Ezetimibe and 0.356 ppm for Lovastatin & Epilovastatin for Simvastatin impurities. Hence the present method can be applied successfully for the quantification of finished dosage form in the combined formulations of Ezetimibe and Simvastatin.

Keywords:

Ezetimibe, Simvastatin, HPLC, Development, Validation