Table 4. Summary of process validation results

Parameters Results
HCT AML TEL
System suitability tR (minutes) 5.123 8.758 11.308
%RSDtR 0.14 0.10 0.09
Peak area Spic (μAU.s) 921378 230373 4247032
%RSDSpic 0.15 0.14 0.15
Apparent theoretical plate number 14661 52046 53666
Tailing factor 1.1 1.0 1.1
Rs 2.8 22.8 14.9
Specificity Figure 4 Figure 4 Figure 4
Linearity Regression correlation equation ŷ=38201.8689x ŷ=24344.3812x ŷ=54915.8383x
Correlation coefficients R 0.9997 0.9996 0.9996
Linear concentration range (ppm) 12.52 – 37.55 5.00 – 15.01 40.01 – 120.02
Accuracy Average recovery rate (%) 99.96 99.57 99.31
%RSD (n = 9) 0.27 0.12 0.26
Repeatability Average content of test sample (%) 99.58 101.05 101.15
%RSD (n = 6) 0.51 0.68 0.54
Intermediate precision Average content of test sample (%) 99.61 101.21 101.43
%RSD (n = 6) 0.53 0.57 0.52
F test và t test (n1 = 6 và n2 = 6; α = 0.05) There is no significant difference There is no significant difference There is no significant difference
Range (ppm) 20.02 – 30.04 8.01 – 12.01 64.01 – 96.01
Robustness System suitability of standard mixture solution; RSD (%) Buffer amonium dihydrophos phate pH 3.2 RSD % peak area 0.25 0.15 0.14
RSD % retention time 0.71 0.79 0.68
Buffer amonium dihydrophos phate pH 2.8 RSD % peak area 0.27 0.50 0.21
RSD % retention 0.55 0.85 0.69