Answer / rc reddy

The question is why linearity in method validation ? In fact
, the linearity is to prove that the method is capable pf
producing the response linearly or proportionally to the
amount present the sample.

Answer / k.praveen kumar macleods pharm

If the method is linear or not from certain range suppose
in assay validation the range is 50% to 150% we are
injecting minimum 6 levels and also Calculate the regration
line the correlation coefficient should be less than 0.999
Here regration line equation is y=mx+c

where y = Regration line
m = Slope
c = Intercept.

and also calculate residual sum of squares from theorical
and practical

Answer / sridhar chinta

Linearity is done in hplc method validation to show that the
method is linear through out the concentration range i.e.
the hplc method can give results according to the set
concentration , for instance if 1x is the area obtained for
50% solution then for 100% solution it should bee 2X i.e.
and so on. So for every hplc method lineariy is a must

how to prepare low ppm solution from high ppm solution ?

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what is the limit of Correlation for IR test compare to the standard and test

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In Analytical method development related substance method when did follow w/w method when did follow area normalisation method

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diference b/w packed &capilary columns

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in HPLC injection volume is increase ,R.T will increase ?

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why require to add enzymes in capsules dissolution only? is it require to tablet also?

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Why dissolution test performed on six jar?

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In lcms analysis some times we get sodium and potassium adducts. if the compound is havine sodium ions how can we confirm wether sodium is from sample or it is a adduct?

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if out of two set of results of moisture analysis first 1 is passing, second one is failing, is it oos ? or vice a versa first 1 is failing and second one is passing. for information mean value to be reported and in mean value the substance is ppassing, is it oos or normaal mean value to be considered?

1 Answers   JBCPL,

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