TABLE X

Summary of Difficulties and Advantages of the Three Methods

ConceptTOC-VCSNTOC-VWPHPLC
Maintenance cost+++++++
Validation/method qualification time consumed/year+++
Qualification cost/year++++
Analysis standard time (calibration curve + samples)+++++++
Reactants cost+++++++++
Staff+++++++++
Standard cost/analysis+++++++++
% obtained recovery (API A′)75%71%69.8%
DL (ppm C)0.00680.00020.0664
QL (ppm C)0.02270.00060.2215
Method precision (CV %, 1 ppm)6.524.562.23
Accuracy (% recovery, 1.43 ppm)10590100
Accuracy (% recovery, 2.87 ppm)10974101
Accuracy (% recovery, 5.70 ppm)1069599
Standard requiredUniversal (potassium phthalate)UniversalSpecific (API)