摘要
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 HPLC method for the assay of sodium Danshensu and protocatechuic aldehyde in Do, hen Chuanxiongqin injection and to evaluate the uncertainty. Methods HPLC was performed with methanol -0.2 % glacial acetic acid as the mobile phase at a detection wavelength of 280 nm. Influencing factors of uncertainty arising from the procedure of measurement were evaluated. Results The contents of sodium Danshensu and protocatechuic aldehyde were （0.4384± 0.0026 ） mg/mL and （0.0740 ± 0.0006 ）mg/mL respectively. Reference substance amount, dilution and the accuracy of method had great contributions to the uncertainty of assay. Conclusion The evaluation of uncertainty provides a mathematical judgment method for improving the credibility of content determination of sodium Danshensu and protocatechuic aldehyde in Danshen Chuanxiongqin injection. This method has practical significance for quality control of Danshen Chuanxiongqin injection.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2015年第4期546-549,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
