Resumen

ULLAH KHAN, ISLAM; KAUSAR, TAYYABA; ASHFAQ, MUHAMMAD  y  SHARIF, SHAHZAD. DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF EZETIMIBE AND LOVASTATIN IN HUMAN PLASMA. J. Chil. Chem. Soc. [online]. 2010, vol.55, n.4, pp. 461-464. ISSN 0717-9707.  doi: 10.4067/S0717-97072010000400011.

In the present study conditions were optimized for the development and validation of a simple, sensitive and isocratic reverse phase high performance liquid chromatographic method for the simultaneous determination of ezetimibe and lovastatin in human plasma using gemfibrozil as internal standard. After a single step extraction with acetonitrile, satisfactory elution of both the analytes along with internal standard was achieved on a Merck C-18 column using a mixture of 0.1 M ammonium acetate pH 5.0 and acetonitrile in the ratio of (28:72, v/v) at a flow rate of 1.5 ml/min. The detection was carried out at a wavelength of 240 nm using a photodiode array detector. The method was linear in the concentration range of 0.2-25 |xg/ml for ezetimibe and 0.4-50 |xg/ml for lovastatin. The extraction recovery of analytes was greater than 85 % and within day and between day precision was also satisfactory. The method was validated by performing its linearity, recovery, precision, LOD/LOQ values and stability of solutions. The total eluting time for the analysis is less than twelve minutes. As the plasma peaks did not interfere with the peaks of analytes so the method can be used for the determination of ezetimibe and lovastatin in human plasma and may possibly be for the pharmacokinetic study.

Palabras clave : HPLC; plasma; diode array detector; gemfibrozil.