Stability Indicating Method Development and Validation for the Determination of Armodafinil in Pharmaceutical Tablet Dosage Form by RP-HPLC
Therapeutic drug monitoring in terms of quality is very much important in pharmaceutical industries. Some of the barriers are like finding out the purity and maintaining uniformity content in pharmaceutical dosage form. To overcome such problems, the present research deals with the development of a stability indicating reverse phase HPLC with PDA detector method for the determination of Armodafinil Agilent XDB-C18, 150 × 4.6 mm, 5 μm or Equivalent column. The flow rate was kept at 1.0 ml/min and the injection volume 10 mL and the run time is 8 min and drug Rt is 3.354. The separation was performed at 30°C. Eluents were monitored by PDA detector set at 223 nm. The developed method was statistically validated and results for the linearity is 0.999 and for System suitability, theoretical plates are 2500 and its tailing factor is 1.64, Precision is 0.1, LOQ is 1.00 μg/ml, LOD is 0.33 μg/ml, accuracy is 100.19, Robustness (flow rate, mobile phase) is complied.
Nalini Kanta Sahoo*, Ramya G, Harini D, Tarun Kumar Padhiary