Simultaneous estimation of simvastatin and ezetimibe by RP-HPLC in pure and pharmaceutical dosage form

A simple, precise and rapid RP-HPLC method was developed for the simultaneous determination of simvastatin and ezetimibe in combined pharmaceutical dosage forms. The method was carried out on a Shim-pack, RP-C18 column using a mixture of acetonitrile: methanol: buffer (triethylamine pH-3) in the ratio 15:45:40 and detection was done at 240 nm using external standard method as quantitation. The linearity range of simvastatin and ezetimibe were 0.5 to 20 μg/ml. The intra-day and inter-day precision were in the range of 1.02-1.43 and 0.53-0.94 for simvastatin, 0.241.29 and 0.93-1.32 for ezetimibe. Key word: Simvastatin , Ezetimibe, Tablets, RP-HPLC. Although the combinational use of simvastatin and ezetimibe is continuously increasing, there are very few HPLC8,9 methods for the simultaneous estimation of simvastatin and ezetimibe reported in literature. The availability of an HPLC method with high sensitivity and selectivity will be very useful for the simultaneous determination of simvastatin and ezetimibe in combined dosage forms. The developed method can be successfully applied to quality control and other analytical purposes.