Nghiên cứu xây dựng quy trình định lượng colecalciferol trong viên nang mềm calci và vitamin D bằng phương pháp HPLC

A reverse-phase HPLC method for determination of colecalciferol (Vitamin D₃) in calcium carbonate and vitamin D soft capsules was developed: Column – Nucleodur C18 ISIS (25 cm × 4.6 mm, 3 μm); detector – UV (265 nm); mobile phase – acetonitrile:water (88:12); flow rate – 1.5 ml/min. After the addition of vitamin D₂ and basic hydrolysis, vitamin D₃ was extracted with n-pentane. After evaporation and dilution in ethanol, vitamin D₃ was chromatographically determined. The method was validated observing the ICH guidelines: The linearity was good at the range of 47.6 – 476.3 IU·mL⁻¹ (r = 0.9989); RSD of intra-and inter-day precision variations < 2.0%; mean recovery was

99.95 ± 1.21% (RSD = 1.21%). For quantitative purpose, the method was adequate and applicable to quality control of colecalciferol in soft capsules.

Keywords: Soft capsules, vitamin D₃, vitamin D₂, calcium carbonate.

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