Abstract
This paper discusses the development of a stability-indicating reversed-phase LC method for analysis of cholecalciferol as the bulk drug and in formulations. The mobile phase was acetonitrile–methanol–water 50:50:2 (v/v). The calibration plot for the drug was linear in the range 0.4–10 μg mL−1. The method was accurate and precise with limits of detection and quantitation of 64 and 215 ng, respectively. Mean recovery was 100.71%. The method was used for analysis of cholecalciferol in pharmaceutical formulations in the presence of its degradation products and commonly used excipients.
Similar content being viewed by others
References
DeLuca F (2004) Am J Clin Nutr 80:1689S–1696S
Merck (1997) Manual of medical research information. Disorders of nutrition and metabolism—salt balance. Merck Research Laboratories, New Jersey, pp 671–673
Sweetman S (2002) Nutritional agents and vitamins—vitamin D. In: Martindale—the complete drug reference, 33rd edn. Pharmaceutical Press, London, pp 1391–1393
Koshy K, Beyer W (1984) Analytical profile of vitamin D3 (cholecalciferol). In: Florey K (ed) Analytical profiles of drug substances, vol 13. Academic Press, Dublin, pp 656–658
Krzek J, Moniczewska M, Zabierowska-Ślusarczyk G (1999) Acta Pol Pharm 56(4):261–266
Krzek J, Moniczewska M, Zabierowska-Ślusarczyk G, Lee Y (2004) Method validation for HPLC analysis of related substances in pharmaceutical drug products. In: Chan CC, Lam H, Lee YC, Zhang XM (eds) Analytical method validation and instrument performance verification. Wiley, New York, pp 27–48
Skoog D, Holler F, Nieman T (1998) High performance liquid chromatography, principles of instrumental analysis, 5th edn. Saunders College Publishing, Philadelphia, pp 725–726
United States Pharmacopeial Convention (2005) The United States pharmacopeia, USP NF 29, High performance liquid chromatography. The United States Pharmacopeial Convention, pp 2644–2651
United States Pharmacopeial Convention (2005) The United States Pharmacopeia, USP NF 29, Validation of compendial methods. The United States Pharmacopeial Convention, pp 3050–3053
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Desai, N.D., Singh, P.P., Amin, P.D. et al. Stability-Indicating LC Method for Assay of Cholecalciferol. Chroma 69, 385–388 (2009). https://doi.org/10.1365/s10337-008-0914-x
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1365/s10337-008-0914-x