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various methos to calculate precision in validation methods in HPLC?

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various methos to calculate precision in validation methods in HPLC?..

Answer / kumar

Precision will be expressed in two parts 1) system precision or repeatability -we can determine %rsd of same preparation with replicate injections 2)method precision or reproducibility or ruggedness or intermediate precision-we can determine %rsd of impurity content in replicate preparations and same experiment will be determine in different analysts,different instruments etc...

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various methos to calculate precision in validation methods in HPLC?..

Answer / santosh k sahoo

3 ways.
1. Repeatability: 3 concentration (n=3) or one concentration i.e.100% (n=6).
2. Intermediate Precision: samples to be run by either different analyst or different instrument or different days.
3. Reproducibility: samples to be run in 2 different labs.

In cases where reproducibility has been performed, intermediate precision is not needed 

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