System Suitability in HPLC Analysis
System Suitability in HPLC Analysis
What is System Suitability?
System Suitability Testing (SST) is a set of analytical checks performed before and during analysis to ensure that the HPLC system and method are capable of producing accurate, precise, and reproducible results.
It is a mandatory GMP/ICH requirement to confirm that the chromatographic system meets predefined criteria before sample analysis.
Purpose
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Verify the performance of the HPLC system and column.
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Detect instrument or method issues early.
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Ensure reliability of analytical results.
Common System Suitability Parameters in HPLC
| Parameter | Purpose | Acceptance Criteria (Example) |
|---|---|---|
| Retention Time (tR) | Confirms analyte identity & reproducibility | %RSD within method limit |
| Resolution (Rs) | Ensures separation between peaks | Rs ≥ 2 (method-dependent) |
| Theoretical Plates (N) | Column efficiency | N ≥ 2000 (depends on method) |
| Tailing Factor (T) | Peak symmetry | T ≤ 2 |
| Capacity Factor (k’) | Adequate retention | k’ > 2 |
| %RSD of Peak Area | Precision check for replicate injections | Typically ≤ 2% |
| Signal-to-Noise Ratio (S/N) | Sensitivity check | Meets method-specific requirement |
Procedure
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Prepare and inject system suitability solution (standard).
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Record chromatographic parameters.
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Compare results to method acceptance criteria.
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Proceed with sample analysis only if SST passes.
Regulatory References
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ICH Q2(R1) – Validation of Analytical Procedures.
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USP <621> – Chromatography.
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GMP guidelines for QC operations.