VALIDATION AND EVALUATION OF AN HPLC METHOD FOR QUANTIFICATION OF VITAMIN D3 IN PHARMACEUTICAL FORMULATIONS
DOI:
https://doi.org/10.48047/wy5sw824Keywords:
LINEARITY, ACCURACY, PRECISION, VITAMIN-D3, HPLC,LODAbstract
In accordance with the guidelines provided by ICH Q2 (R1), the analytical procedure that you have described for quantifying vitamin D-3 through the use of HPLC is quite comprehensive and has been thoroughly validated. The apparatus appears to be reliable, as it consists of a C-18 column, a mobile phase consisting of methanol and water, and detection at 264 nm, which is an adequate wavelength for vitamin D-3 identification
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References
Siddiqui M.R., AlOthman Z.A., Rahman N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem. 2017;10:S1409–S1421. doi:10.1016/j.arabjc.2013.04.016.2. Taraji M., Haddad P.R., Amos R.I.J., Talebi M., Szucs R., Dolan J.W., Pohl C.A. Rapid Method Development in Hydrophilic Interaction Liquid Chromatography for Pharmaceutical Analysis Using a Combination of Quantitative Structure–Retention Relationships and Design of Experiments. Anal. Chem. 2017;89:1870–1878. doi:10.1021/acs.analchem.6b04282.
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