Abstract
In the present work, we developed and validated five spectrophotometric methods for determination of magnesium orotate dihydrate in distilled water, pH 1.2, 4.5, 6.8, and 7.4 buffer systems. These media were selected to extend the applicability of the developed methods from the development of dosage forms to regular quality control. In all media, linear correlation was observed over the concentration range from 1 to 25 μg/mL. The developed methods were found to be selective and specific to the determination of magnesium orotate dihydrate in the presence of various excipients, as well as accurate, precise, and robust (the percent relative standard deviation was found to be less than 2%, and the percent recoveries were between 98 to 102%). The developed methods were also found to be highly sensitive, since the detection and quantification limits were found to be less than 1 μg/mL. The degradation kinetics studies reveal the stability of magnesium orotate dihydrate against hydrolysis (acidic or basic), oxidation, photolysis, and thermal treatment.
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