A novel RP-HPLC method has been developed for the estimation of tramadol hydrochloride (TH) in the tablet dosage form using Phenomenox C18 column of dimensions 250 x 4.6 mm i.d., particle size 5 μm utilizing the system of buffer: acetonitrile (55:45 ratio) as the mobile phase at a flow rate of 1 ml/min, employing 271 nm detector, where the drug was eluted at 6.21 minutes. The newly developed method was suitably validated according to the ICH guidelines further for linearity, range, accuracy, precision and robustness. The proposed method was observed to be linear (r2 = 0.998) over the range concentration range of 12.5-75.0 μg/ml. The method was both accurate with the recovery of 99.5% and % RSD of less than 0.1% and extremely precise as indicated by the % RSD value of 0.1% in both the cases of intra- and inter-day studies. The method was also found to be much robust to deliver very accurate results, if the chromatographic conditions were altered. While the analysis, no interference from the diluents or excipients were encountered. The research will render a very simple, exceptionally cost-effective, extremely accurate, quite precise and highly reproducible method for the routine quality analysis of tramadol hydrochloride in tablets.
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