Research Article

A Stability Indicating UPLC Method for the Determination of Tramadol Hydrochloride: Application to Pharmaceutical Analysis

Table 4

Method robustness.

ConditionModificationMean Peak area ± SD*%RSDMean Rt ± SD*%RSDMean theoretical plates ± SD*%RSDMean tailing factor ± SD*%RSD

35°C 0.10 2.015 ± 0.0060.30 3467 ± 59.65721.10 ± 0.020.18
Temperature40°C6136916 ± 106950.17 2.007 ± 0.0070.333953 ± 85.36161.01 ± 0.010.10
45°C6186601 ± 67230.111.99 ± 0.0060.303998 ± 56.56411.11 ± 0.020.18

Mobile phase composition40 : 606134526 ± 101150.161.9 ± 0.0060.304021 ± 10536621.02 ± 0.050.49
50 : 506188507 ± 94370.152.0 ± 0.0060.30 4068 ± 70.56731.01 ± 0.040.40
60 : 406345681 ± 99860.161.99 ± 0.080.40 4098 ± 86.97120.98 ± 0.050.51

0.357107242 ± 85200.122.01 ± 0.050.253987 ± 101.16531.02 ± 0.020.20
Flow rate0.406112464 ± 88170.142.006 ± 0040.20 4016 ± 88.84191.02 ± 0.030.29
0.455455471 ± 90530.171.99 ± 0.050.253987 ± 101.16531.02 ± 0.020.20

224 nm7024544 ± 156080.222.00 ± 0.060.303136 ± 95.16031.01 ± 0.030.30
Wavelength226 nm 0.182.01 ± 0.080.40 4268 ± 101.3101.01 ± 0.040.40
228 nm7131156 ± 128450.18 2.00 ± 0.0040.203334 ± 88.58661.02 ± 0.080.78

*Mean value of three determinations.