Žane Temova, Robert Roškar, Stability-Indicating HPLC–UV Methodology for Vitamin D3 Dedication in Options, Dietary Dietary supplements and Prescribed drugs, Journal of Chromatographic Science, Quantity 54, Challenge 7, 1 August 2016, Pages 1180–1186, https://doi.org/10.1093/chromsci/bmw048
Introduction
The intention of the current report was to develop a easy and quick stability-indicating technique for the evaluation of vitamin D3 in stability research in addition to in pharmaceutical preparations utilizing a reversed-phase HPLC technique with UV detection. Degradation merchandise, shaped below stress situations (hydrolysis, oxidation, photolysis and thermal degradation), have been moreover elucidated by appropriate gear (LC–DAD–MS) to substantiate the stability-indicating nature of the developed technique. The tactic that covers the dedication of vitamin D3 in numerous matrixes was efficiently validated in accordance with the Worldwide Convention on Harmonization (ICH) pointers.
Experimental
A identified quantity of vitamin D3 was added to 2.0 mL of 0.1% orthophosphoric acid, into which two tablets of preparation E or F have been additional added and subjected to the extraction process, as beforehand described. Unspiked preparations and methanol customary resolution of vitamin D3 containing the added quantity have been individually extracted and analyzed. Two weighed tablets have been added to 2.0 mL of 0.1% orthophosphoric acid right into a centrifuge tube and vortexed for two min.
Outcomes
A (IU/mL) 4,000 4588 ± 12 4656 ± 21 4659 ± 25 4634 ± 23 98.3 B (IU/mL) 20,000 20,026 ± 132 19,636 ± 82 20,308 ± 56 19,990 ± 194 99.6 C (IU/mL) 2,000 2751 ± 13 2622 ± 11 2509 ± 12 2627 ± 70 100.1 D (IU/mL) 4,000 3934 ± 4 4015 ± 18 4049 ± 5 4000 ± 34 100.0 E (IU/tbl) 400 620 ± 6 636 ± 7 584 ± 7 613 ± 14 99.2 F (IU/tbl) 400 498 ± 13 457 ± 2 494 ± 6 483 ± 13 100.3
Open in new tab
Desk IV.Common Content material of Vitamin D3 in IU ± Normal Error of the Imply (n = 3) Preparation
. A (IU/mL) 4,000 4588 ± 12 4656 ± 21 4659 ± 25 4634 ± 23 98.3 B (IU/mL) 20,000 20,026 ± 132 19,636 ± 82 20,308 ± 56 19,990 ± 194 99.6 C (IU/mL) 2,000 2751 ± 13 2622 ± 11 2509 ± 12 2627 ± 70 100.1 D (IU/mL) 4,000 3934 ± 4 4015 ± 18 4049 ± 5 4000 ± 34 100.0 E (IU/tbl) 400 620 ± 6 636 ± 7 584 ± 7 613 ± 14 99.2 F (IU/tbl) 400 498 ± 13 457 ± 2 494 ± 6 483 ± 13 100.3
Open in new tab
A (IU/mL) 4,000 4588 ± 12 4656 ± 21 4659 ± 25 4634 ± 23 98.3 B (IU/mL) 20,000 20,026 ± 132 19,636 ± 82 20,308 ± 56 19,990 ± 194 99.6 C (IU/mL) 2,000 2751 ± 13 2622 ± 11 2509 ± 12 2627 ± 70 100.1 D (IU/mL) 4,000 3934 ± 4 4015 ± 18 4049 ± 5 4000 ± 34 100.0 E (IU/tbl) 400 620 ± 6 636 ± 7 584 ± 7 613 ± 14 99.2 F (IU/tbl) 400 498 ± 13 457 ± 2 494 ± 6 483 ± 13 100.3 Preparation
.
Dialogue
Good accuracy by way of excessive recoveries and precision (Desk IV) confirmed the suitability of the established technique for the quantification of vitamin D3 in liquid (A, B, C and D) and in strong preparations (E and F). The proposed technique permits direct dedication of vitamin D3 in numerous liquid pharmaceutical preparations and dietary dietary supplements with none pretreatment. Additionally it is relevant for the quantification of vitamin D3 in strong dosage varieties after a easy and speedy pretreatment.
Conclusion
The described reversed-phase HPLC technique is favorable in contrast with different printed HPLC–UV strategies due to its stability-indicating nature, brief run time and extensive analytical vary with excellent linearity, accuracy and precision. The proposed technique permits the dedication of vitamin D3 and its associated compounds in a single chromatographic run and is appropriate for the evaluation of the steadiness of vitamin D3. A quick and easy stability-indicating HPLC–UV technique for quantification of vitamin D3 within the presence of its degradation merchandise was developed and validated in accordance with the ICH pointers.