Uncertainty Evaluation on Determination of Pirfenidone in Human Plasma by HPLC

OBJECTIVE To establish the measurement uncertainty in determination of pirfenidone in plasma by HPLC. METHODS The various factors influencing the uncertainty in the whole process of determination, were all analyzed and estimated. The uncertainty of each variable was calculated. The expanded uncertainties and combined uncertainty were analyzed with all the components. RESULTS The expanded uncertainty for low(0.511 0 mg·mL^-1), medium(2.038 mg·mL^-1) and high(19.95 mg·mL^-1) level of pirfenidone were 0.105 1, 0.137 6, 1.069 mg·mL^-1, respectively(P=95%). CONCLUSION The uncertainly of the method is mainly caused by the calibration curve. The method is applicable for the uncertainty evaluation of pirfenidone determination in human plasma by HPLC.