HPLC assay method validation of tablet | Precision Section

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PRECISION OF INJECTION


Aim: To confirm the repeatability of retention time and peak area for replicate (Six) injections of Respective standard

Method:       
Prepare a standard solution using the procedure described in Method. Record the standard weight and potency.

Perform six injections of the standard solution, record the area and retention time for each of the standard’s peak. Calculate the mean and % RSD.



Acceptance Criteria:
The % RSD of peak areas should be less than 2% and that of retention time less than 1%.


Results:

Standard
Lot Number
Weight (mg)
Purity (as is)
Name of Standard
_______
_____mg
____%


Injection No.
Active Ingredient
Retention Time (mins)
Peak Area
1


2


3


4


5


6


Mean


SD


%RSD



Comments/Conclusion:
______________________________________________________________________________________________________________________________________
___________________________________________________________________

Performed by:_______________                               Checked by:_______________
(Sign/Date)                                                                (Sign/Date)

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