Does this analytical methods has an internal standard (IS) or QC sample, why is this so?
Analytical Method
Plasma imatinib concentrations were determined us- ing a high-performance liquid chromatography/tan- dem mass spectrometry (HPLC/MS/MS) assay.16 This method was validated for both monkey and human plasma. Plasma samples were prepared using a C18 solid-phase extraction procedure (3M Empore C8 ex- traction disk). Sample extracts were analyzed using reversed-phase chromatography with a Waters Sym- metry column (Waters Corp., Milford, MA) followed by detection with a Sciex API 3000 mass spectrometer (PE Biosystems, Foster City, CA). The lower limit of quanti- fication was 4 ng/mL, and the assay was fully vali- dated. The accuracy and precision from prestudy vali- dation were 97.8% ± 6.4% at the lower limit of quantification and 91.5%-102% ± 0.4%-8.2% over the entire concentration range of 1 to 10,000 ng/mL.
Does this analytical methods has an internal standard (IS) or QC sample, why is this so?
Analytical Method
Plasma imatinib concentrations were determined us- ing a high-performance liquid chromatography/tan- dem mass spectrometry (HPLC/MS/MS) assay.16 This method was validated for both monkey and human plasma. Plasma samples were prepared using a C18 solid-phase extraction procedure (3M Empore C8 ex- traction disk). Sample extracts were analyzed using reversed-phase chromatography with a Waters Sym- metry column (Waters Corp., Milford, MA) followed by detection with a Sciex API 3000 mass spectrometer (PE Biosystems, Foster City, CA). The lower limit of quanti- fication was 4 ng/mL, and the assay was fully vali- dated. The accuracy and precision from prestudy vali- dation were 97.8% ± 6.4% at the lower limit of quantification and 91.5%-102% ± 0.4%-8.2% over the entire concentration range of 1 to 10,000 ng/mL.
