Optimization and validation of a fast supercritical fluid chromatography method for the quantitative determination of vitamin D3 and its related impurities

Andri, Bertyl; Lebrun, Philippe; Dispas, Amandine; Klinkenberg, Régis; Streel, Bruno; Ziémons, Eric; Marini, R.D.; Hubert, Ph.

doi:10.1016/j.chroma.2017.01.090

Cited by 42 publications

(12 citation statements)

References 46 publications

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“…The probable impurities of Cholecalciferol are very similar to the respective structure of drug substances 23 . Cholecalciferol is practically insoluble in water and freely soluble in acetonitrile, methanol and ethanol.…”

Section: Discussionmentioning

confidence: 78%

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

Mahajan¹,

Deshmukh²,

Farooqui³

2021

Int J Life Sci Pharm Res

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The main objective of this research work was to develop and validate, a new gradient, highly sensitive, specific and stability indicating Reverse Phase HPLC method for quantitative determination of known, unknown impurities and degradant impurities profiling for Cholecalciferol tablets. No Pharmacopoeial method is available to quantify known, unknown impurities and degradants profiling for Cholecalciferol tablets. The impurities were separated on the Hypersil BDS column (150 mm x 4.6mm, 3µm) with a mobile phase of mixture of Trifluoroacetic acid buffer and acetonitrile with flow rate of 1.5 mL minute -1. The column compartment was maintained at 40°C and the detection wavelength was at 265nm. Cholecalciferol, its known impurity and unknown impurities have been well resolved from each other. Recovery of the known and unknown impurities found between 80% to 120% as per ICH guideline. Method found linearity over the working concentration range with acceptance criteria of correlation coefficient greater than 0.99. Method precision and intermediate precision results found with percentage relative standard deviation of impurity content less than 10% for replicated analysis of test samples. A stress study was conducted with a drug product that was exposed to different conditions of acid, base, oxidation, heat, humidity and photolytic degradation. Cholecalciferol was found to degrade significantly under Photolytic, Thermal and Alkaline stress conditions. The degradation products were well resolved from Cholecalciferol and its impurities. For each stress condition, peak purity of Cholecalciferol was assessed using the Photodiode Array detector and found homogeneous in nature. The mass balance for stress study was found in between 95% and 105%. Thus, proving the stability indicating nature of the analytical method. The developed method was validated as per ICH guidelines. The method found accurate, precise, linear, robust, rugged, specific and stability indicating in nature.

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Section: Discussionmentioning

confidence: 78%

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

Mahajan¹,

Deshmukh²,

Farooqui³

2021

Int J Life Sci Pharm Res

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“…Nevertheless, these results are satisfactory for vitamin D quantification in encapsulation systems, where the concentration of encapsulated active substances usually ranges from 1% to 10% (Silva et al, 2017). Other authors reported values of RSD% between 1.07 and 1.31% for vitamin D 3 quantification by HPLC-UV (Almarri et al, 2017), and between 0.822 and 0.896% RSD% for vitamin D 3 by supercritical fluid chromatography (Andri et al, 2017).…”

Section: Analytical Validationmentioning

confidence: 87%

Analytical validation of an ultraviolet–visible procedure for determining vitamin D3 in vitamin D3-loaded microparticles and toxigenetic studies for incorporation into food

et al. 2021

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“…A wide number of applications have been explored with ultrafast SFC separations, including pharmaceutical drugs, − dietary supplements, , steroid compounds, − forensic samples and drugs of abuse, − cosmetics, , and biofuels and coal tar, with MS detection becoming increasingly important in methods utilizing SFC. − Beyond these analytical-scale separations, SFC has also been applied for rapid preparative purifications, which is especially advantageous as a “greener” analytical technique with less solvent waste than a typical preparative-scale separation. , On the opposite column size regime, microfluidic SFC was reported for the first time, with both chiral and achiral separations achieved in under 30 s . Combined with a microfluidic board designed for flow control that is compatible with SFC mobile phases, there is significant potential for miniaturized SFC techniques to increase in use in coming years.…”

Section: Supercritical Fluid Chromatographymentioning

confidence: 99%

High-Throughput and Ultrafast Liquid Chromatography

et al. 2019

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Optimization and validation of a fast supercritical fluid chromatography method for the quantitative determination of vitamin D3 and its related impurities

Cited by 42 publications

References 46 publications

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

Stability Indicating Method for Known and Unknown Impurities Profiling for Cholecalciferol Tablets

Analytical validation of an ultraviolet–visible procedure for determining vitamin D3 in vitamin D3-loaded microparticles and toxigenetic studies for incorporation into food

High-Throughput and Ultrafast Liquid Chromatography

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