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Subject: column cleaning gradient chromat. Валидация метода.Accuracy
Accuracy was estimated by recovery percent, calculated as ratio between the slope of the regression line of the standard solution spiked with SAM-e and the slope of the standard solution.
Since the API degrades rapidly producing the impurity under examination only one injection for level was performed.
In Figure 17 is reported the chromatogram recorded for solution Spike 3 with concentration of ADN 4.2 mg/L, MTA 10.7 mg/L, SAH 5.9 mg/L and SAM-e 2000 mg/L. The peak of SAM-e is not shown in the chromatogram because it elutes on the column cleaning gradient. Что здесь column cleaning gradient?? п.с. Spike 3 = раствор примесей с добавлением АФИ Заранее благодарен.
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