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Introduction:  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.
Objective:  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.   
Methodology: 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.
Results and conclusions: 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.

Milena Pérez, CIDEIM

Directora del Laboratorio Biofarmacéutico, CIDEIM, Cali, Colombia.

Gloria Ramírez, CIDEIM

Asistente de Investigación, CIDEIM, Cali, Colombia.

Mauricio Pérez, CIDEIM

Unidad de Epidemiología y Bioestadística, CIDEIM, Cali, Colombia.

Piedad Restrepo, CIDEIM

Coordinadora Unidad de Estudios Biofarmacéuticos, CIDEIM, Cali, Colombia.
Pérez, M., Ramírez, G., Pérez, M., & Restrepo, P. (2007). 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. Colombia Medica, 38(1), 13–20.


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