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目的建立测定丹参川芎嗪注射液中丹参素钠和原儿茶醛含量的方法,并对测量结果进行不确定度评定。方法采用高效液相色谱法,以甲醇-0.2%冰醋酸为流动相,检测波长为280 nm,分析测定过程和步骤,量化具体的不确定度分量。结果丹参川芎嗪注射液中丹参素钠含量为(0.4384±0.0026)mg·m L-1,原儿茶醛的含量为(0.0740±0.0006)mg·m L-1,对照品称量、稀释过程和方法准确度对合成不确定度的贡献较大。结论测量不确定度的评价为丹参川芎嗪注射液中丹参素钠和原儿茶醛含量测定的可信度提供一种数学判断方法,对其质量控制具有指导意义。
Objective To establish a method for the determination of sodium danshensu and protocatechuic aldehyde in Salvia miltiorrhiza Ligustrazine injection, and evaluate the uncertainty of measurement results. Methods The mobile phase was methanol-0.2% glacial acetic acid and the detection wavelength was 280 nm. The analytical procedure and procedure were used to quantify the specific components of uncertainty. Results The contents of Danshensu sodium in Salviae miltiorrhizae ligustrazine injection were (0.4384 ± 0.0026) mg · m L-1, and the content of protocatechuic aldehyde was (0.0740 ± 0.0006) mg · m L-1. The control samples were weighed and diluted And the accuracy of the method contributes more to the synthesis uncertainty. Conclusion The evaluation of measurement uncertainty provides a mathematical judgment method for the determination of the content of Danshensu sodium and protocatechuic aldehyde in Danshen Ligustrazine Injection and is of guiding significance for its quality control.