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) samples at low, medium, and high concentrations (30, 450, and 1800 ng/mL) were detected 6 times within 3 days. Intra- and inter-day precision and accuracy were calculated according to the concentrations of QC samples calculated by the intraday standard
selectivity, matrix effects, linearity, precision, accuracy, recovery, and stability [ 8 – 12 ]. Pharmacokinetic Study About 8.0 mg hapepunine was dissolved in purified water containing 0.01% HCl and prepared into a 1.0 mg
centrifugation at 14,900 g for 10 min, the supernatant (2 μL) was injected into the UPLC–MS/MS system for analysis. Method Validation Rigorous tests for selectivity, linearity, accuracy, precision, recovery, and stability
determination of selectivity, linearity, precision, accuracy, matrix effects, recovery, process efficiency, and stability, was performed in rat plasma according to Food and Drug Administration (FDA) guidance [ 16 ]. Selectivity
the lowest concentration in the calibration curve of atractylenolide III, with an acceptance value set at ±20%. 2.7.3. Accuracy and Precision Six replicates of tthe QC samples, prepared at three
, precision, specificity, detection limit, quantification limit, linearity, range, ruggedness, and robustness experiments were executed. The proposed method was evaluated as per International Conference on Harmonization (ICH) guidelines [ 27 , 28
the U.S. Food and Drug Administration (FDA). The validation included selectivity, matrix effect, linearity, precision, accuracy, recovery, and stability [ 13 , 14 ]. The selectivity of the UPLC–MS/MS method was evaluated by analyzing blank
. Method Validation Inter-day precision and accuracy for alectinib were determined by analyzing 10 QC samples on different days. Precision was characterized by the coefficients of variation (%CV) whereas accuracy was expressed as a relative
/S). Similarly, LOQ was defined on the basis of the SD of the response and S of calibration curves at levels approximating the LOQ according to the following formula: LOQ = 10(SD/S) [ 18 ]. Precision and Accuracy The intra- and
quantitatively determined with suitable accuracy (percent error <20%) and precision (coefficient of variation <20%). The analyte response at the LLOQ level should be at least five times greater than the analyte response of the zero calibrator. The lower limit of
