Abstract:The residue of toxic and harmful element impurities in the drug endangers human health, and the main components of the compound antihypertensive drug- Olmesartan Medoxomil and Hydrochlorothiazide Tablets are olmesartan medoxomil (C29H30N6O6) and hydrochlorothiazide (C7H8ClN3O4S2), which is a commonly used and effective blood pressure control compound preparation, in which the accurate determination of the impurity content of toxic and harmful elements is indispensable in quality control. The International Council for Harmonization of Technical Requirements for the Registration of Drugs for Human Use (ICH) Harmonization Guidelines: Elemental Impurities Guiding Principles Q3D (R2) and USP (United States Pharmacopeia) <232> both put forward very clear and strict limits for the control of elemental impurities that are toxic and harmful to the human body, although the Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0411 and USP (United States Pharmacopoeia) < 233>The general rules for the determination of elemental impurities in drugs are given, but the determination methods of specific drugs are not given. A rapid and accurate method for the determination of seven toxic and harmful elements in Olmesartan Medoxomil and Hydrochlorothiazide Tablets was established by microwave digestion instrument and inductively coupled plasma emission spectrometer, and the detection limits of the method were Cd 0.0002 μg/mL, Pb 0.004 μg/mL, As 0.0119 μg/mL, Hg 0.0062 μg/mL, Co 0.0005 μg/mL, V 0.0009 μg/mL, Ni 0.001 μg/mL, The limits of quantification of methods were Cd 0.0006 μg/mL, Pb 0.0133 μg/mL, As 0.0398 μg/mL, Hg 0.0206 μg/mL, Co 0.0015 μg/mL, V 0.003 μg/mL l, Ni 0.0035 μg/mL. The RSD value of precision was 0.35%~6.82%. The recoveries were 96.24%~101.37% for Cd, 93.33%~95.13% for Pb, 96.01%~98.77% for As, 88.22%~90.97% for Hg, 91.30%~96.21% for Co, 102.33%~102.36% for V, 97.67%~98.78% for Ni, and the results were satisfactory. The results of three brands of Olmesartan Medoxomil Hydrochlorothiazide Tablets at home and abroad were far lower than the ICH-Q3D(R2) and USP<232> limiting requirements.