Abstract：Objective Taking the newly added zearalenone determination method for Coicis Semen as an example, this paper expounds how to confirm and verify the method when the legal standard is used for the first time in the laboratory. Methods The specificity, accuracy, precision, detection limit, quantitative limit and linearity of zearalenone determination method were validated. Results The linear relationship of zearalenone was good, r=0.9991, the blank solution had no interference peak, the recovery was 83.2%-90.2%, RSD was 3.1%, the detection limit was 0.1 μg/kg, the quantitative limit was 3.8 μg/kg, the results were in accordance with the requirements of "9101 analytical method validation guidelines" published in 2020 edition of Chinese Pharmacopoeia. Conclusion Methods the contents of validation should be examined according to the complexity of the analytical method and the characteristics of the samples tested.
谢燕. 薏苡仁新标准中玉米赤霉烯酮测定法的方法确认及验证过程[J]. 中国当代医药, 2022, 29(25): 36-39.
XIE Yan. Confirmation and verification of zearalenone determination method in new standard of Coicis Semen. 中国当代医药, 2022, 29(25): 36-39.
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