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Table 1 Experimentally recorded system suitability method parameters for BQF and their recommended limits

From: RP-HPLC method development and validation for bedaquiline fumarate to evaluate its forced degradation behaviour and stability in official dissolution media

Sr. No. System suitability parameters Acceptance criteria Experimental values
1. Capacity factor (k’) ≥ 2 2.4
2. Injection precision (n ≥ 5) (area and RT) RSD ≤ 1% RSD < 1% (n = 6)
3. Resolution (Rs) > 2 4.86
4. USP tailing factor (T) ≤ 2 1.08
5. Theoretical plates (N) > 2000 3490