Regression Analysis in Method Validation

1.0 OBJECTIVE

To lay down a procedure for performing Regression Analysis in Method Validation

2.0 SCOPE

This SOP is applicable for for performing Regression Analysis in Method Validation in Company Name

3.0 BACKGROUND

NIL                                       

4.0 RESPONSIBILITY

4.1 All Analytical research personnel shall follow the SOP.      

4.2 Group leader of Analytical  research to ensure the proper and safe disposal of excess samples, expired chemicals, impurities ,reference standard and empty reagent bottles or solvent bottles.          

4.3 Head Analytical research or his designee to ensure overall compliance.

5.0 PROCEDURE

5.1 Regression analysis in Linearity

Calculate the linearity from 50,75,100,125 and 150 % sample solution.

The data obtained in the sample solution analysis is as given in the table.

 

  5.2 Now draw the graph with concentration of x-axis and area on y-axis by selecting the line graph. 

 

5.3 There is any problem with label on x-axis , right click on the chart and select the “Select data” option. The pop-up will come, in that select the “Edit” button to change the horizontal axis label

5.4 Then click on Edit, you will get pop-up for selecting data as shown bellow

5.5 Click on select range, select the values in the concentration as shown below 

5.6 After doing that you are going to have the following graph

5.7 After having the above graph, click on the blue line, then right click on that, so that you will get pop-up, in that select the “add trend line” option.

5.8 If you click on “ Add trend line you will get another popup as shown below 

5.9 Select the default “linear” Radio button for trend/regression and Check Display Equation on chart and Display R-square value on chart. Change the Trendline name by selecting the custom radio button and entering the “Regression line” as value.

From the above chart

Y=18816x + 18460

R2(This is R square)=1

As per linear equation  Y=mx+b

Then

Slope=18816

Y-intercept=18460

R2(square)=1