HPLC Calibration Parameters in pharma

HPLC Calibration Parameters:

There are a total 9 parameters for HPLC calibration, these are as follows;

1. Flow Rate Accuracy
2. Injector Precision
3. Injector Linearity
4. Wavelength accuracy of the detector
5. Detector Linearity
6. Gradient Composition Accuracy
7. Carry Over
8. Temperature Accuracy
9. Drift and Noise

These are all calibration parameters performed while calibration.

HPLC Calibration Parameters Acceptance Criteria:

The acceptance criteria for all calibration parameters are as follows;

1. Flow Rate Accuracy:

The acceptance criteria for Flow Rate accuracy is ± 0.5% of the set flow rate.

2. Injector Precision:

The acceptance criteria for Injector Precision is, % RSD of RT and the area should be NMT 1.0%

3. Injector Linearity:

The acceptance criteria for Injector Linearity is, the correlation coefficient should be NLT 0.99

4. Wavelength accuracy of the detector:

The acceptance criteria for wavelength accuracy is;

i. Maxima should be between 203-207nm when run at a wavelength from 202-208nm.

ii. Manima should be between 271-275nm when run at a wavelength from 270-276nm.

iii. Maxima should be between 243-247nm when run at a wavelength from 242-248nm.

5. Detector Linearity:

The acceptance criteria for detector linearity is, the correlation coefficient is NLT 0.99.

6. Gradient Composition Accuracy:

The acceptance criteria for gradient composition accuracy is, % RSD should be less than 3.0%.

7. Carry Over:

The acceptance criteria for carryover is, the % carryover should be NMT 0.1%. (It may vary from organization to organization)

8. Temperature Accuracy:

The acceptance criteria for temperature accuracy is, ± 2°c of the set temperature.

9. Drift and Noise:

The acceptance criteria for drift and noise is,

Drift: ≤ 0.01 AU/Hr

Noise: ≤ 0.000125AU

Abbriviation: NMT= Not More Than, NLT= Not Less Than

Frequency for HPLC Calibration:

The frequency for HPLC calibration is once in 6 months.

Most of the organizations are following these hplc calibration parameters for calibration.

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