Precision in validation

System Precision:

UV/ Visible Spectrophotometer: Measure the six absorbances of working standard solution of drug substance or intermediate at fixed or established wavelength. Calculate the % RSD of the absorbance. The % RSD should not be more than 10%.

HPLC: Follow the validated “Assay by HPLC”, set the chromatographic condition on HPLC and  inject the six replicate of working standard solution of drug substance or intermediate. Measure the area response of the main peak of six replicate. Calculate the % RSD of the area response of main peak. The % RSD should not be more than 10%

Method Precision:
UV/ Visible Spectrophotometer:  Prepare the working standard solution of drug substance or intermediate according to its acceptance criteria by weighing six times separately and perform the measurements by UV. Calculate the % RSD of the absorbance. The % RSD should not be more than 10%

HPLC : Prepare separately six working standard solutions, inject individually and measure the area response of the main peak. Calculate the % RSD of the area response of main peak. The % RSD should not be more than 10%.