IDENTIFICATION AND QUANTIFICATION OF RELATED SUBSTANCES OF VITAMIND3 IN ITS PREPARTIONS BY RP-HPLC

Syed Shah; Archana M.

doi:10.29121/shodhkosh.v5.i5.2024.2782

Authors

Syed Shah Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, Chennai-600117, Tamil Nadu, India.
M. Archana Assistant Professor, Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Chennai-600117, Tamil Nadu, India

DOI:

https://doi.org/10.29121/shodhkosh.v5.i5.2024.2782

Keywords:

RP- HPLC, Cholecalciferol (CHL), Related Substances, Vitamind3, N-Pentanol

Abstract [English]

An analytical approach for quantifying vitamin D3 related substancesmethod was developed by using high-performance liquid chromatography (HPLC). The separation was achieved using a hypersil Silica, 250mm x 4.6mm, 5µm column, and a mobile phase composition of n-pentanol and n-hexane was used. The wavelength of the chromatogram was 265 nm at a temperature of 20℃, the flow rate was 2.0 mL/min. The method was specific, and linear within the range of 50%-150% and has demonstrated good recovery, inter day and intraday precision. As well as robustness, the detection and quantification limits were found to be within the limits at .001 and 0.0037 g/ml, respectively. The developed method ismore precise, accurate, specific and robust to determine the related substances of Vitamin D3 in its preparations and validated according to ICH guidelines Q2(R1).

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