In vitro Monitoring of Macro and Microelements in Multimineral Preparations across Dissolution Profiles by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES)

Abstract

In this study, inductively coupled plasma optical emission spectrometry (ICP OES) was used for multi-element analysis in five multimineral preparations from a dissolution test, in accordance with the United States Pharmacopeia (USP 34 method): apparatus 1, 75 rpm and 900 mL of 0.1 mol L -1 HCl. Element releases in all samples (minimum-maximum in %) were: Ca (14.5-28.2), Cr (54.5-68.0), Cu (2.9-10.0), Fe (4.0-34.3), Mg (6.0-25.2), Mn (2.6-51.2), V (0.0-51.4) and Zn (1.5-107.3). The concentrations of Al, Ba, Cd, Co, Mo, Pb and Se were below the limit of detection of ICP OES. Accuracy was assessed by microwave digestion and recovery values of 94-102%. USP 34 method indicates that not less than 75% of the elements described on the product label must be dissolved in 1 h. Only the release of Zn met the recommendations. The results indicated the need for greater quality control in multivitamin preparations. The dissolution test was validated in order to contribute to Brazilian and other pharmacopoeias. Keywords: multimineral, multivitamin preparations, dissolution profiles, ICP OES IntroductionThe concern about medicine quality has been growing and led the pharmaceutical industry to research, develop and control medicine production, across reliable and effective analytical methods in order to guarantee the quality control of these products. Dissolution tests evaluate the quality of a drug product; obtain the dissolution profile of a drug from a dosage form; identify formulations that present a potential hazard to drug bioavailability and serve as a useful tool in the development of formulations.1,2 Dissolution tests predict in vitro bioequivalence (BE) of a drug. The obtention and comparison of dissolution profiles are important tools for establishing the similarity of pharmaceutical forms containing the active principle of interest. [3][4][5][6] Mineral absorption by living organisms is a dynamic and complex process, dependent on several factors, including levels of ingested element, age, gastrointestinal pH, environmental conditions, nutritional status, element disabled or not, the presence of antagonistic minerals or other nutrients. 7 The consumption of food supplements containing vitamins and minerals has increased considerably in recent decades. Dietary supplements or nutritional products contain vitamins, minerals, herbal products, tissue extracts, proteins and amino acids and other products, and are consumed with the goal of improving health, physical performance and prevent diseases. 8,9 Multivitamin and multimineral preparations in solid pharmaceutical forms (tablets, caplets and capsules) contain the following nutrients: vitamin A, complex-B, C, D, E, K and minerals such as magnesium, zinc, calcium, iodine, selenium, copper, manganese, chromium, molybdenum and others. 10,11 Depending on the chemical form and production conditions, different products may release these substances erratically, affecting absorption. Therefore, in vitro monitoring of the release of these minerals into In vitro Monitoring of Macro...