Development and validation of an AAS method for quantitation of class 1 and class 2a elemental impurities in tablets

According to the international harmonization conference guide ICH Q3D (R1) published on March 22, 2019, the methods by which the limits for elemental impurities can be determined by applying inductively coupled plasma (ICP) analysis in drugs were anHayırunced. Due to the difficult availability of ICP devices and the cost of procurement from scratch, method adaptation was achieved using the same sample preparation techniques as atomic absorption spectroscopy (AAS), which is more common in laboratories and the AAS device. The ICH guide complies with the lowest detection and quantitative detection limits, detection limits of graphite furnace atomic absorption spectroscopy equipment (GF AAS). Method development and validation studies were carried out for the most critical and the worstcase limit Class 1 and Class 2A metals specified in the relevant guideline, and the drugs in tablet form samples which are used most frequently. Class 1 arsenic (As), cadmium (Cd), mercury (Hg), lead (Pb), and class 2A cobalt (Co), nickel (Ni), vanadium (V). Sample preparation was performed by microwave-assisted acid digestion using a mixture of 65% HNO3 and 37% HCl (5:1, v/v).