Performance test of WATERS HPLC equipment

Pump

Nominal flow rate

Test of the accuracy of the programmed flow

0.5 mL/min

2 mL/min

0.5 mL/min

2 mL/min

Average deviation Dm (%)

1.2

1.45

0.6

1.25

European Pharmacopoeia Standard 8.2: Dm < 5%

Compliant

Compliant

Compliant

Compliant

Pump Repeatability Test (n = 6)

0.5 mL/min

2 mL/min

0.5 mL/min

2 mL/min

RSD (%)

0.428

0.252

European Pharmacopoeia Standard 8.2: RSD ≤ 0.5%

Compliant

Compliant

Injector

Propylparaben (PPB) peak area

Injector repeatability (n = 6)

1660295.33

RSD (%)

0.72

RSD limit (%)

1

European Pharmacopoeia Standard 8.2: RSD < RSD limit

Compliant

Linearity test of the injector volume (n = 5)

volume = f (PPB peak area)

Coefficient of determination (R2)

0.9993

European Pharmacopoeia Standard 8.2: R2 > 0.99

Compliant

Detector

Peak area of caffeine

Linearity test of the detector (n = 5)

Volume = f (Caffeine peak area)

Coefficient of determination (R2)

0.9994

European Pharmacopoeia Standard 8.2: R2 > 0.99

Compliant