HPLC-UV Method Development and Validation for Vitamin D₃ (Cholecalciferol) Quantitation in Drugs and Dietary Supplements

Erratum

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 D₃).
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 anddietary supplements presented in the Russian Federation.
Materials and methods. Determination of vitamin D₃ 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.

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