Table 9 Summary of Validation Parameters for MCPA

Linearity

Correlation Coefficient = 0.998

Correlation Coefficient NLT 0.97

Precision

0.11% RSD

% RSD NMT 2.0

Trueness

Conc. (mg/L)

% Recovered

% Recovery within

80–120%

150

99.3%

200

99.4%

250

99.5%

300

99.3%

350

99.3%

Repeatability

(with respect to Instrument and Analyst)

0.36% RSD

Reproducibility

(with respect to Instrument)

HPLC–20AT

HPLC–10AT

RSD ≤ 2.0%

0.36% RSD

0.20% RSD

[with respect to various Labs (ILC)]

Average

0.16% RSD

Detection and quantitation limit

LOD

LOQ

–

1.08 mg/L

3.62 mg/L

Robustness

Change

% RSD

% RSD NMT 1.5

Flow rate = 1.3 mL

0.20%

Flow rate = 1.5 mL

0.36%

Flow rate = 1.7 mL

0.05%

(Mobile Phase)

Methanol: Water

950: 50

0.24%

(Mobile Phase)

Methanol: Water

900: 100

0.36%

(Mobile Phase)

Methanol: Water

850: 150

0.20%