电感耦合等离子体质谱法测定胶囊壳中铬含量

Determination of Chromium Content in Capsules by Inductively Coupled Plasma Mass Spectrometry

依据《中国药典》(2020版)中胶囊壳铬含量检测的电感耦合等离子体质谱法对市售的80个胶囊壳样品中铬污染采用单因子指数法进行评估。采用电感耦合等离子体质谱法测定胶囊壳中的铬,线性相关性达到0.9999,检测限为0.0192μg/L,定量限为0.0639μg/L,精密度质控样品7次测定RSD为2.4%,测定结果满足胶囊壳中铬的检测要求。对市售的药品及保健食品中胶囊壳中铬的测定,检出率为98%,均值为0.88 mg/kg,最大值为1.60 mg/kg,铬单因子污染指数P为0.44,污染程度分级为优良。

Research the specific steps and verification the Chinese Pharmacopoeia(2020 edition)for detection of chromium in capsule shells with inductively coupled plasma mass spectrometry,and evaluated by single factor index method for chromium contamination in 80 commercially available capsule shell samples.Determination of chromium in capsule shells with inductively coupled plasma mass,the linear correlation reached 0.9999,the detection limit is 0.0192μg/L,the limit of quantitation is 0.0639μg/L,the RSD of the quality control sample for 7 times tests is 2.4%,and the results are all in the satisfactory range,to meet the detection requirements of chromium in capsule shell.Determination of chromium in capsule shells of commercially available pharmaceuticals and health foods,the detection rate is 98%,the average is 0.88 mg/kg,the maximum value was 1.6 mg/kg,P value is 0.44,the pollution level is rated as excellent.