ICP-MS Analysis and Validation by Microwave Digestion System for Determination of Heavy Metals in Allergy and Cancer Drugs Taken Orally

Abstract

The drug, one of the most important products that cannot be replaced in the field of health, prevents all threats to human health when used in place and dosage. Therefore, it has an important place in public health. Determination of the amounts and impurities of various elements used in drug production is an important parameter. According to the ICH Q3D(R1) international compliance conference guide, methods by which limit concentrations can be determined for elemental impurities by applying inductively coupled plasma (ICP) analysis to drugs are specified. In this study, the sample preparation step in the analysis of 23 elements in cancer and allergy drugs in tablet form was optimized by microwave digestion, and method development and validation studies were carried out for these drugs with inductively coupled plasma-mass spectrometry (ICP-MS). When the analysis results were evaluated, it was seen that the data obtained were by the limit values specified in the ICH. Detection and quantification limits of the developed method, and relative standard deviation values were determined, and recovery studies were carried out by adding standards at 4 different concentrations to determine the method's precision. The correlation coefficients obtained for heavy metals in this study ranged from 0.9993 to 1.000, while the detection limit was found to be between 0.001 and 1.756 µg/L. Thus, the reliability and precision of the validation study developed has been determined and it has been shown that this method can be used in similar drug samples.

Keywords

• validation
• heavy metal
• microwave digestion
• inductively coupled plasma-mass spectrometry
• drug
• validasyon
• elementel safsızlık
• mikrodalga çözünürleştirme
• i̇ndüktif eşleşmiş plasma-kütle spektrometrisi
• i̇laç