The current study aimed to develop a simple, accurate, precise and rapid RP- HPLC method and subsequent validation as per ICH guidelines for the determination of tapentadol hydrochloride in pure form and synthetic mixture. The method was performed using HPLC system with a sunfire TM C18 5 µm column (4.6 mm i.d.× 150 mm) at ambient temperature. The optimum mobile phase consisted of acetonitrile: distilled water (85:15 v/v) containing triethylamine 10-5 %V/V and glacial acetic acid 3x10-4% V/V. The pH of the mobile phase was adjusted to pH 3.5. The mobile phase was delivered isocratically at a flow rate of 1.0 mL/min with UV detection at 271 nm. Tapentadol hydrochloride was eluted at 2.1 min. The calibration plots constructed using the optimized chromatographic conditions displayed good linear relationship in the concentration range of (1-45) μg/mL with r=0.9998; the % recovery of the drug was found to be 100.96±0.6 %; the LOD was (0.22) µg/mL; the LOQ was (0.66) µg/ml. The recovery of tapentadol from the bulk drug & synthetic mixture was 100.96 & 100.3 % respectively. The method has been successfully applied for analysis of bulk drug & synthetic mixture and is suitable for the routine quality control analysis.
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