TY - JOUR AU - Pérez, Milena AU - Ramírez, Gloria AU - Pérez, Mauricio AU - Restrepo, Piedad PY - 2007/03/30 Y2 - 2024/03/29 TI - Validation of an analytical method for the determination of valsartan in human plasma by HPLC/UV with addition standard using losartan as an internal standard. JF - Colombia Medica JA - Colomb Med VL - 38 IS - 1 SE - Original Articles DO - 10.25100/cm.v38i1.469 UR - https://colombiamedica.univalle.edu.co/index.php/comedica/article/view/469 SP - 13-20 AB - <strong>Introduction:</strong>  The validation concept refers to the statistical evaluation of the results obtained in the application of analytic technics, by appropriately documented and demonstrative tests that a method is sufficiently reliable to produce the result foreseen under defined conditions, like they are: analytic system, concentration interval, infrastructure and human talent.<br /> <strong>Objective:</strong>  To describe the validation process of the analytic method for the valsartan quantification in human plasma by HPLC-UV and its application in pharmacokinetic, bioavailability and bioequivalence studies of products that contain the active principle valsartan.    <br /> <strong>Methodology:</strong> A method for detection and quantification of valsartan in human plasma has been developed using an isocratic elution on reversed phase liquid chromatography with ultraviolet detection at a single wavelength (265 nm) and the addition  standard method. Losartan was used as an internal standard. This method involves a solid-phase drug extraction (valsartan and losartan) from plasma using C8 cartridges. Separation was achieved on a C18 reversed phase column and the mobile phase consisted of 45% acetonitrile and 55% phosphate buffer (adjusted to pH 2.7 ± 0.1 with phosphoric acid). The assay has been vali-dated over a concentration range of 0.05 to 20 µg/ml with addition of valsartan 2.5 µg/ml. <br /> <strong>Results and conclusions:</strong> Calibration curve was linear in the described concentration range. The reproducibility, stability and recovery of the method were evaluated. Determination of valsartan in human plasma by HPLC/UV method was accurate and precise with a quantitation limit of  1.485 µg/ml. The method was sufficiently sensitive for pharmacokinetic studies of valsartan in human plasma. ER -