ABSTRACT:
Background and the purpose of the study: A suitable reverse phase high-performance liquid chromatography (RP-HPLC) and high-performance liquid thin layer chromatography (HPTLC) method for determination of Simvastatin (SIM) and Ezetimibe (EZE) in bulk drug and tablet formulation. The present study describes a simple, rapid, sensitive, reliable, and economic RP-HPLC and HPTLC methods for determination of simvastatin and ezetimibe in bulk drug and tablet formulation which is more feasible than reported RP-HPLC and HPTLC assays. Methods: The RP-HPLC separation was achieved on a Hypersil C-18 column (250 mm X 4.6 mm id, 5?m particle size) using acetonitrile– Water (80: 20, v/v) mobile phase at a flow rate of 1.0 mL/min at ambient temperature. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F254 using hexane: toluene: ethyl acetate: acetic acid (3:1:6:0.2, v/v/v/v/v) mobile phase. Quantitation was achieved with UV detection at 235 nm over the concentration range 4–24 ?g/mL for both drugs, with mean recoveries of 100.81 ± 0.28 and 100.27 ± 0.66% for SIM and EZE, respectively, using the HPLC method. Quantitation was achieved with UV detection at 235 nm over the concentration range of 1600–4800 ng/spot for both drugs, with mean recoveries of 100.34 ± 0.55 and 100.54 ± 0.83% for SIM and EZE, respectively, using the HPTLC method. Conclusion: Proposed study describes new RP- HPLC and HPTLC methods for the estimation of simvastatin and ezetimibe in bulk drug and tablet formulation. The method was validated and found to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore the proposed method can be used for routine analysis for estimation of simvastatin and ezetimibe in its bulk drug and pharmaceutical tablet formulation.