Simultaneous quantification of calcium and magnesium in pharmaceutical ingredients and supplements (Injections, and tablets) using carboxyl moiety stationary phase HPLC column with refractive index detector

Calcium (Ca) and magnesium (Mg) are two essential minerals that help keep bones strong and healthy. Our bodies do not create calcium and magnesium naturally, so we must receive them from food or supplements. Ca and Mg supplements in various dosage forms, such as tablets and injectables, are available to prevent deficiency. It is essential for determining the levels of Ca and Mg in drug substances and pharmaceutical compounds. Methodological approaches such as inductively coupled plasma mass spectrometry (ICP-MS), ion chromatography (IC), atomic absorption spectroscopy (AAS), capillary electrophoresis (CE), and titration are available for estimating Ca and Mg. The current research devised a novel isocratic reverse-phase HPLC method, an alternative approach to ICP-MS. It uses 0.7% v/v formic acid as the eluent, a carboxyl functional group-packed HPLC column, and a refractive index detector (RID) to determine Ca and Mg content. The method was validated as per regulatory requirements. The method has the optimal sensitivity (quantification threshold: 2 μg/ mL and detection threshold: 0.6μg/mL), is specific and inexpensive, and is thus well suited for the detection and quantification of Ca and Mg in drug substances and in supplements, including injections and tablets.