Division 2.3.6 Performance criteria and other requirements for the determination of an analyte by 2-D TLC coupled to full-scan UV/VIS spectrometric detection
United Kingdom
Two-dimensional HPTLC and co-chromatography are mandatory.
The RF values of the analyte shall agree with the RF values of the standards within ±5 %.
The visual appearance of the analyte shall be indistinguishable from that of the standard.
For spots of the same colour the centre of the nearest spot should be shall separated from the centre of the spot of the analyte by at least half the sum of the spot diameters.
The spectrum of the analyte shall not be visually different from the spectrum of the standard, as described for full-scan UV/VIS detection.
In the case computer-aided library searching and matching are used, the comparison of the spectral data in the test samples to that of the calibration solution has to exceed a critical match factor. This factor shall be determined during the validation process for every analyte on the basis of spectra for which the criteria described above are fulfilled. Variability in the spectra caused by the sample matrix and the detector performance shall be checked.