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目的建立HPLC法测定板蓝根颗粒中(R,S)-告依春含量的不确定度评定方法。方法采用HPLC法测定板蓝根颗粒中(R,S)-告依春含量,建立数学模型,分析各因素引起的不确定度,评定各分量不确定度,合成不确定度,并计算测定结果的扩展不确定度。结果扩展不确定度为0.21μg·g-1,最终报告结果为:HPLC法测定板蓝根颗粒中(R,S)-告依春的含量为(50.17±0.21)μg·g-1。结论本法可用于不确定度评定,建立的HPLC测定板蓝根颗粒中(R,S)-告依春的含量测定方法是合理可行的,可用于板蓝根颗粒的质量控制。
OBJECTIVE To establish an HPLC method for the determination of (R, S) -induced spring content in Banlangen granules. Methods The (R, S) -anthrene content of Radix isatidis was determined by HPLC. The mathematical model was established. The uncertainty caused by each factor was analyzed. The uncertainty of each component, the uncertainty of synthesis and the expansion of the determination results were calculated uncertainty. The results of the extended uncertainty of 0.21μg · g-1, the final report as follows: HPLC determination of Banlangen particles (R, S) - Evodia content was (50.17 ± 0.21) μg · g-1. Conclusion This method can be applied to the evaluation of uncertainty. The established method for the determination of (R, S) -derivative in Banlangen by HPLC is reasonable and feasible and can be used for the quality control of Banlangen.