Development and validation of a methodology for the quantitative determination of vitamin D3 in tablets

Introduction. The active pharmaceutical substance of the tablets is vitamin D3 (cholecalciferol), therefore, quantitative analysis methods are being developed to determine it. The methodology given in the general pharmacopoeia article of the OFS was taken as a basis.1.2.3.0017.15 "Methods of quantitative determination of vitamins" of the State Pharmacopoeia of the Russian Federation XV edition. This article proposes a quantitative analysis of vitamin D3 using the method of high-performance liquid chromatography (HPLC). Goal. Development and validation of a methodology for the quantitative determination of the active pharmaceutical substance vitamin D3 in tablets. Material and methods. To develop and validate a method for the quantitative determination of vitamin D3 in tablets, a high-performance liquid chromatography method was used: chromatograph Chromosome A02 (Chromosome Engineering, Russia) equipped with an ECD2000 UV detector (ECOM, Czech Republic), a column Luna C18(2) 150×4.6 mm was used for separation. The analysis and validation characteristics were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation XV edition. Results. It was found that during HPLC analysis, the average content of cholecalciferol in the drug was 126.2±3 micrograms/ml (100.9% of the declared value; the relative error of determination was ±2.38%). A validation assessment of the proposed technique was carried out in terms of specificity, linearity, precision (level of convergence), which confirmed its suitability for authenticating and quantifying cholecalciferol in a medicinal product. Conclusion. The results obtained indicate the possibility of using the method of high-performance liquid chromatography in the isocratic mode for the quantitative determination of the active pharmaceutical substance vitamin D3 in tablets coated with an intestinal soluble shell for the treatment and prevention of vitamin D-dependent nosologies.