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.
Abstract
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.
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Keywords
- Valsartan
- Losartan
- Solid-phase extraction
- Addition standard method
- HPLC/UV
Submitted
2009-11-20
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590 |
How to Cite
Pérez, M., Ramírez, G., Pérez, M., & Restrepo, P. (1). 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 Médica, 38(1), 13-20. https://doi.org/10.25100/cm.v38i1.469
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Original Articles
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