During Hplc analysis, we run 5 injection as system suitability from one weight and 2 injection as control standard by taking another weight. What is the significance?
This is done during HPLC analysis to check accuracy of standard preparation of set 1 (5 injections of standard solution in set 1 as system suitability) and set 2 (1 or 2 injections) by separately weighing standard in two sets and doing further dilutions as per analytical method. The %ratio is calculated as follows. The standard area ratio should be between 98% to 102%
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Are there any more reasons? What are the references?
This is performed as a part of System suitability to check accuracy of standard preparation. This ensures that the standard is prepared accurately with the required precision because the analytical results of samples depend on the standard accuracy BEFORE running the samples. Similarly, the bracketing standard is also injected after every 5-6 (or as per internal SOP) injections and at the end of HPLC sequence/run to ensure that the HPLC system and standard performance are satisfactory so that the samples’ results are accurate and reliable.
Please refer to the USP <621> Chromatography / System suitability chapter and individual monographs of drug products, APIs, and excipients for HPLC system suitability requirements.
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