what is the need of calulation of RRF of impurity in HPLC
analysis?
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Answer Posted / ichinnakamisetti
Relative Response Factor (RRF) is an analytical parameter used in chromatographic procedures to control
impurities/degradants in drug substance and drug product. RRF is used to correct the difference in
detector response of impurities with analyte peak. RRF is established by slope method with linear range
of solutions. Different Pharmacopoeias refer the term RRF differently.
As per United States Pharmacopoeia (USP) The Relative response factor, is the ratio of the responses of
equal amounts of the Impurities and the drug substance1
. USP refers RRF as Correction factor or
Response factor or Relative response factor.
As per European Pharmacopoeia (Ph.Eur) The Relative detector response factor, commonly referred as
Response Factor, expresses the sensitivity of a detector for a given substance relative to a standard
substance. The correction factor is reciprocal of the response factor2
. Ph.Eur refers RRF as Correction
factor or Response factor.
As per British Pharmacopoeia (BP) The Response Factor is a relative term, being the response of equal
weights of one substance relative to that of another in the conditions described in the test3
. BP refers RRF
as Response factor.
Establishment of RRF is required to avoid the stability issues with standards, to reduce the cost
on preparation of Impurity Standards, to reduce Maintenance of Impurity Standards, due to the lack of
donation of Impurity Standards, difficulty in synthesis and isolation of Impurity Standards, for
convenience and time saving. Relative Response factor (RRF) is used in different stages: Phase 1 to
Phase 4 studies, in drug purity tests, Mass balance tests, in limit tests, In stability indicating methods etc.
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