Table 5 Comparison of RCP values determined by the new TLC method by scanner or dose calibrator against the RCP obtained by the Ph.Eur. method (HPLC and PC) taken as reference (standard deviation k=2)
| Â | Â | Ph.Eur. | 2-strip method | Accuracy | ||||
|---|---|---|---|---|---|---|---|---|
Date | Validation | (HPLC&PC) | TLC Scanner | Dose calibrator | Difference to Ph.Eur. method | |||
| Â | Â | [%] | [%] | [%] | TLC Scanner | Dose calibrator | ||
| Â | Â | Â | Â | Â | [%] | [%] | ||
27.04.2016 | No 1 | 97 | 96.7 | ± 0.8 | 97.1 | ± 0.8 | -0.3 | 0.1 |
28.04.2016 | No 2 | 96.9 | 96.7 | ± 0.5 | 97.1 | ± 0.8 | -0.2 | 0.2 |
29.04.2016 | No 3 | 95.8 | 96.1 | ± 0.4 | Not measured | 0.3 | N.A. | |
29.04.2016 | No 4 | 95.6 | ± 0.5 | 96.1 | ± 0.5 | -0.2 | 0.3 | |