Table 2. Different Columns Used for the Official Ph. Eur. Method and the Reported Results According to SST Criteria.
| column no. | column | comment |
|---|---|---|
| 1 | Venusil AQ C18 (150 mm × 4.6 mm, 3 μm) | The SST criteria passed (Figure 4a); Hp/Hv = 4–7; S/N = 10; tRa = 12.679 min. |
| 2 | Gemini C18 (150 mm × 4.6 mm, 3 μm) | The SST criteria passed (Figure 4b); Hp/Hv = 4–5; S/N = 20; tRa = 9.602 min. |
| 3 | Synergi Hydro-RP (150 mm × 4.6 mm, 4 μm) | The SST criteria did not pass (Figure 4c); tRa = 9.355 min; coelution of impurity A with the prednisolone peak. |
| 4 | Luna C18(2) (150 mm × 4.6 mm, 4 μm) | The SST criteria did not pass (Figure 4d); tRa = 9.817 min; insufficient separation of impurity A and the prednisolone peak. |
| 5 | Gemini NX-C18 (150 mm × 4.6 mm, 5 μm) | The SST criteria did not pass (Figure 4e); tRa = 7.136 min; coelution of impurity A with the prednisolone peak. |
| 6 | Luna Omega Polar C18 (150 mm × 4.6 mm, 3 μm) | The SST criteria did not pass (Figure 4f); tRa = 10.332 min; coelution of impurity A with the prednisolone peak. |
| 7 | Kinetex F5 (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4g); tRa = 4.441 min; different elution orders of the impurities; possible coelution of the impurities with the prednisolone peak; poor retention. |
| 8 | Kinetex Biphenyl (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4h); tRa = 5.697 min; coelution of impurity A with the prednisolone peak; different elution orders of the impurities; poor retention. |
| 9 | Kinetex C18 (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4i); tRa = 5.656 min; insufficient separation of impurity A and the prednisolone peak; poor retention. |
| 10 | Kinetex Phenyl-Hexyl (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4j); tRa = 5.199 min; different elution orders of the impurities; poor retention. |
| 11 | Kinetex XB-C18 (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4k); tRa = 6.816 min; coelution of impurity A with the prednisolone peak; poor retention. |
| 12 | Kinetex Polar C18 (150 mm × 4.6 mm, 2.6 μm) | The SST criteria did not pass (Figure 4l); tRa = 6.524 min; coelution of impurity A with the prednisolone peak; poor retention of compounds. |
a
tR is the retention time of the prednisolone peak.