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Development and validation of an HPLC-UV method for pazopanib quantification in human plasma and application to patients with cancer in routine clinical practice

Abstract: BACKGROUND:
Pazopanib, a new oral angiogenesis inhibitor, has demonstrated clinical activity against multiple solid tumors and was approved for the treatment of patients with advanced renal cell carcinoma. As an exposure-response relationship has been observed for pazopanib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to develop and validate a selective and precise high performance liquid chromatography-ultraviolet method for the measurement of pazopanib in plasma from patients with cancer.
METHODS:
After liquid-liquid extraction with diethyl ether, pazopanib and gefitinib (internal standard) were separated using isocratic elution on an Ultrabase C18 column using a mobile phase consisting of a mixture in vol/vol proportion of 47:53 of ammonium acetate (pH, 7; 0.02 mol/L) and acetonitrile/methanol (70:30, vol/vol) pumped at a constant flow rate of 1 mL/min. Quantification was performed at 260 nm. Method validation was undertaken as per the guidelines for Bioanalytical Method Validation published by the Food and Drug Administration and European Medicines Agency.
RESULTS:
Calibration curves were linear over the range 0.5-100 mcg/mL. Interday and intraday coefficients of variations were less than 4.5%. The limit of detection and the lower limit of quantification were 0.2 and 0.5 mcg/mL, respectively. Recovery of pazopanib from plasma was >80%.
CONCLUSIONS:
This is the first high performance liquid chromatography-ultraviolet method for pazopanib quantification that has been validated within a wide range of plasma concentrations and is a suitable method for therapeutic drug monitoring of pazopanib.

Full Reference: Escudero-Ortiz, Vanesa, Juan J. Perez-Ruixo, and Belen Valenzuela. “Development and Validation of an HPLC-UV Method for Pazopanib Quantification in Human Plasma and Application to Patients with Cancer in Routine Clinical Practice.” Therapeutic Drug Monitoring 37, no. 2 (April 2015): 172–79. doi:10.1097/FTD.0000000000000121.

Link to full text: https://www.ncbi.nlm.nih.gov/pubmed/25072946

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