During a dissolution analysis, the principal peak was not found in 3rd sample injections. But when re-injected from that vial for investigation, the peak was found. What can be the possible reason?
You should investigate this matter. Most probabilities could be as follows,
- Original 3rd sample might not have got injected into HPLC (Please check for the baseline of this injection).
-Please check if you got a dissolution medium peak for 3rd sample similar to that of other samples.
- Also check for other peaks that were observed similar to those of other samples (1st, 2nd, 4th, 5th & 6th tablet).
- Please check for the ‘Processing method’ used for chromatography.
- Please check for integration parameters of chromatograms set for 3rd sample as compared to those of other samples.
- Please check for satisfactory running of the chromatograph specifically for 3rd sample injection as compared to other samples.
- Please check whether all samples were injected in sequence along with the standard.
- Check for any other observation during chromatographic runs.
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