HPLC-UV Method Development and Validation for Vitamin D 3 (Cholecalciferol) Quantitationin Drugs and Dietary Supplements

I. E. Shohin, E. A. Malashenko, Yu. V. Medvedev, M. N. Bogachuk, S. A. Kulakov, M. A. Paleeva
2021 Drug development & registration  
Introduction. An inadequate diet and living in the northern regions can lead to a lack of vitamin D3 and the development of diseases, including a decrease in immunity. To compensate for the lack of vitamin D, vitamin drugs are used that contain vitamin D in one of its active forms (usually in the form of cholecalciferol, vitamin D 3).Aim. To develop and validate HPLC-UV method for the determination of vitamin D3 in vitamin drugs and to evaluate the content of cholecalciferol in selected drugs
more » ... in selected drugs anddietary supplements presented in the Russian Federation.Materials and methods. Determination of vitamin D 3 was carried out by HPLC with UV detection at a wavelength 266 nm. Sample preparation of vitamin drugs was carried out by extraction with methanol (for liquid dosage forms based on aqueous or triglyceride solutions) and extraction with an aqueous-methanol solution (for solid dosage forms based on water-soluble substances with vitamin D3) in a ratio of 2 to 8 (water-methanol).Results and discussions. The analysis methodology for the parameter "Vitamin D3 (cholecalciferol) content" in vitamin dosage forms by HPLC was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range.Conclusion. The analysis methodology for the parameter "Vitamin D3 (cholecalciferol) content" in vitamin dosage forms by HPLC was developed. The method was validated according to the following validation parameters: specificity; accuracy; precision; linearity; range. The range of the method was 9,5–38 μg/ml. The method was used to determine vitamin D3 in vitamin drugs based on water-soluble forms of vitamin D3, in the form of aqueous solutions and form of fatty acids triglyceridessolutions.
doi:10.33380/2305-2066-2021-10-2-87-99 fatcat:jcmvlnpzxffezogeu75rduczli