In specificity what parametrs are consider why that parametrs
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Answer / sameer
check peak purity of main peak nd known impurity peak.check interference of Main/Known impurity peak in diluent,blank or in placebo
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Answer / manojmishra
The test specificity in analytical method validation is
considred as the identification test.
In this test we considred suitable identification of
substance to be validated as retention time of substance
peak in HPLC and GC, Wavelength in UV, and some suitable
method as colour test or RF value for chemical and TLC
validation.
Therefore, you can consider, %RSD of peak RT,Resolution
between the peak as system suitability etc.
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In HPLC Chromatographic separation Resolution equation is Rs = 1.18 (tR2 –tR1)/wh1+Wh2, Where, tR2 and tR1 is run time of eluent ratios of the distances from the point of application to the centers of the spots and the distance travelled by the solvent front from the point of application (retardation factor), and Wh1and Wh2 , is peak width of at half height. What is 1.18 ?