Research Article
UHPLC-PDA Assay for Simultaneous Determination of Vitamin D3 and Menaquinone-7 in Pharmaceutical Solid Dosage Formulation
Table 6
Robustness study of vitamin D3 and MK-7 by UHPLC.
| Chromatographic conditions | Vitamin D3 | MK-7 | Assay (%) | (min) | | TF | Assay (%) | (min) | | TF | Rs |
| Flow rate: 0.7 | 101.36 | 1.14 | 23540 | 0.95 | 101.23 | 3.34 | 28265 | 0.93 | 27.62 | Flow rate: 0.5 | 101.29 | 1.37 | 23351 | 0.99 | 99.78 | 3.75 | 28233 | 0.98 | 27.59 | (±0.1 mL min−1) | | | | | | | | | | Mobile phase (55 : 45) | 100.17 | 1.26 | 23040 | 0.93 | 99.71 | 3.65 | 28865 | 0.99 | 27.62 | Mobile phase (45 : 55) | 99.53 | 1.25 | 23259 | 0.98 | 100.28 | 3.64 | 28223 | 0.93 | 27.61 | (±5.0 mL) | | | | | | | | | | Column temp. (45°C) | 99.39 | 1.22 | 23390 | 0.97 | 101.36 | 3.62 | 28444 | 0.96 | 27.62 | Column temp. (35°C) | 99.81 | 1.28 | 23287 | 0.96 | 100.51 | 3.61 | 28304 | 0.98 | 27.63 | (±5°C) | | | | | | | | | | Wavelength (267 nm) | 100.52 | 1.27 | 23289 | 0.99 | 100.32 | 3.65 | 28109 | 0.94 | 27.62 | Wavelength (263 nm) | 101.43 | 1.25 | 23401 | 0.96 | 99.83 | 3.63 | 28119 | 0.95 | 27.63 | (±2 nm) | | | | | | | | | | pH: 6.1 | 99.87 | 1.27 | 23540 | 0.96 | 100.34 | 3.64 | 28165 | 0.94 | 27.62 | pH: 5.9 | 100.18 | 1.25 | 23387 | 0.93 | 100.39 | 3.63 | 28338 | 0.95 | 27.65 | (±0.1) | | | | | | | | | |
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: retention time, : theoretical plates, TF: tailing factor, and Rs: resolution.
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