亚甲蓝注射液含量测定取样方法的研究

Research of Sampling Methods for Assay of Methylthioninium Chloride Injection

目的用重量法取样代替体积取样并研究以质量/质量浓度(mg·g-1)的百分比代替质量/体积浓度(mg·m L-1)的百分比来表示亚甲蓝注射液的含量,为提高其含量测定的准确度、精密度和易操作性提供实验依据。方法用电子天平精密称取一定重量的亚甲蓝注射液,经稀释后用高效液相色谱法(HPLC法)和紫外可见分光光度法(UV-Vis法)测定亚甲蓝注射液的含量,并计算出质量/质量浓度(mg·g-1)百分比。结果重量法取样测定亚甲蓝注射液的含量,测定10次,HPLC法平均含量为99.6%,RSD=0.1%,紫外可见分光光度法平均含量为100.0%,RSD=0.1%;移液取样测定亚甲蓝注射液的含量,测定10次,HPLC法平均含量为99.6%,RSD=0.2%,UV-Vis法平均含量为99.9%,RSD=0.2%。结论重量法取样测定亚甲蓝注射液的含量与以往体积取样相比,测定结果的准确度、精密度和实验易操作性更优,且温度对测定结果的影响更小。

OBJECTIVE Using weight sampling method instead of pipette sampling method while defining percentage of mass/mass （ mg· g - 1 ） as format for representing content of methylthioninium chloride injection, instead of mass/volume （ mg· mL- 1 ）. To provide experimental support for improving accuracy, precision and operational ease of assay. METHODS Took samples of methylthioninium chloride injection with using electronic balance, determi- nated assay of it by HPLC method and UV-Vis method after dilution. Then defined percentage of mass/mass （ mg· g-1 ） as format for representing content of it. RESULTS Determinated assay of methyhhioninium chloride injection by HPLC method and UV-Vis method, each for ten times. With using weight sampling method, the average content was 99. 6%, RSD = 0. 1%, （ HPLC method）, 100. 0%, RSD = 0. 1% （ UV-Vis method ）. With using former pipette sampling method,the average content was 99.6%, RSD = 0. 2% （HPLC method） ,99. 9%, RSD = 0. 2% （UV-Vis method）. CONCLUSION Compare weight sampling method to former pipette sampling method, the accuracy, precision and operability of assay were better,meanwhile the effect from temperature was diminished.