ICP-MS Method for Simultaneous Determination of Aluminum, Sodium, and Potassium in Human Albumin Solution for Infusion.

Abstract

Elemental impurities in drug products may pose a risk to patient health. Therefore, maintaining the levels of these impurities below certain limits is essential for patient safety. Human albumin solution, one of the parenteral drugs used for many years, is crucial in various treatments. Also, the European Pharmacopoeia specifies limits for potassium, aluminum, and sodium in this drug. Inductively coupled plasma-atomic absorption spectrometry (ICP-AAS) and ICP-optical emission spectrometry (ICP-OES) are used for detecting elemental impurities. However, neither method can simultaneously analyze all three impurities within the pharmacopeial limits. This study aimed to develop a new method for simultaneously detecting the levels of potassium, aluminum, and sodium in human albumin-based drugs using ICP-mass spectrometry (ICP-MS). The limit of detection (LOD), specificity, linearity, repeatability, and accuracy were examined, and the recovery percentage was calculated. For Na, K, and Al elements, detection limits were calculated as 0.0105767 μg/mL, 0.001748 μg/mL, and 2.0568E - 4 μg/mL, respectively. Precision and reliability of this method have been proven by the linearity regression coefficients that were found as 0.999, 0.999, and 0.995 for Na, K, and Al. In addition, repeatability recovery rates were 98.70%, 98.38%, and 90.83%; accuracy analysis results were 101.45%, 94.53%, and 108.83% for 50% level; 98.26%, 93.93%, and 95.83% for 100% level; 100.48%, 95.90%, and 107.22% for 150% level for Na, K, and Al elements, respectively. This study successfully developed and validated ICP-MS for the simultaneous quantitative determination of the levels of potassium, aluminum, and sodium in human albumin solution.