Research Article
A Stability Indicating UPLC Method for the Determination of Tramadol Hydrochloride: Application to Pharmaceutical Analysis
Table 4
Method robustness.
| Condition | Modification | Mean Peak area ± SD* | %RSD | Mean Rt ± SD* | %RSD | Mean theoretical plates ± SD* | %RSD | Mean tailing factor ± SD* | %RSD |
| | 35°C | | 0.10 | 2.015 ± 0.006 | 0.30 | 3467 ± 59.65 | 72 | 1.10 ± 0.02 | 0.18 | Temperature | 40°C | 6136916 ± 10695 | 0.17 | 2.007 ± 0.007 | 0.33 | 3953 ± 85.36 | 16 | 1.01 ± 0.01 | 0.10 | | 45°C | 6186601 ± 6723 | 0.11 | 1.99 ± 0.006 | 0.30 | 3998 ± 56.56 | 41 | 1.11 ± 0.02 | 0.18 |
| Mobile phase composition | 40 : 60 | 6134526 ± 10115 | 0.16 | 1.9 ± 0.006 | 0.30 | 4021 ± 10536 | 62 | 1.02 ± 0.05 | 0.49 | 50 : 50 | 6188507 ± 9437 | 0.15 | 2.0 ± 0.006 | 0.30 | 4068 ± 70.56 | 73 | 1.01 ± 0.04 | 0.40 | 60 : 40 | 6345681 ± 9986 | 0.16 | 1.99 ± 0.08 | 0.40 | 4098 ± 86.97 | 12 | 0.98 ± 0.05 | 0.51 |
| | 0.35 | 7107242 ± 8520 | 0.12 | 2.01 ± 0.05 | 0.25 | 3987 ± 101.16 | 53 | 1.02 ± 0.02 | 0.20 | Flow rate | 0.40 | 6112464 ± 8817 | 0.14 | 2.006 ± 004 | 0.20 | 4016 ± 88.84 | 19 | 1.02 ± 0.03 | 0.29 | | 0.45 | 5455471 ± 9053 | 0.17 | 1.99 ± 0.05 | 0.25 | 3987 ± 101.16 | 53 | 1.02 ± 0.02 | 0.20 |
| | 224 nm | 7024544 ± 15608 | 0.22 | 2.00 ± 0.06 | 0.30 | 3136 ± 95.16 | 03 | 1.01 ± 0.03 | 0.30 | Wavelength | 226 nm | | 0.18 | 2.01 ± 0.08 | 0.40 | 4268 ± 101.3 | 10 | 1.01 ± 0.04 | 0.40 | | 228 nm | 7131156 ± 12845 | 0.18 | 2.00 ± 0.004 | 0.20 | 3334 ± 88.58 | 66 | 1.02 ± 0.08 | 0.78 |
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*Mean value of three determinations.
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