UTİLİZATİON OF THE STABİLİTY-İNDİCATİNG RP-HPLC METHOD FOR DİETRY SUPPLEMENT CALCİUM OROTATE QUANTİFİCATİON İN CAPSULE DOSAGE FORM

Abstract

A rapid, accurate, and precise HPLC approach for quantifying calcium orotate in capsule dosage form was developed and validated. As optimum conditions for analysis, a C 8 column (250 mm x 4.6 mm, 5μ) was used as the stationary phase, with a mobile phase of 65:35 v/v acetonitrile and 25 mM potassium dihydrogen phosphate buffer (pH 4.7) at a flow rate 1 ml/min and detected at 254 nm. The method showed a 0.999 correlation and an excellent linear response throughout a concentration range of 15–90 μg/ml. Retention lasted for 3.186 minutes. Validation of the method done as per the requiremnts of ICH and subjected to oxidation, photolysis, heat, acid, alkali hydrolysis, and water stress. Degradation byproducts did not affect the ability to detect calcium orotate, hence the approach is stability indicating. The approach may be used to determine calcium orotate in pharmaceutical capsule dose form since the findings of the research were within the parameters of ICH standards.