• ISSN : 2231 - 0541 (Online)
  • 0976 - 3090 (print)
  • NLM ID : 101613942
  • CAS CODEN : PHARN8
  • Frequency : Bi-Monthly

DEVELOPMENT AND VALIDATION OF A SENSITVE RP-HPLC METHOD FOR ANALYSIS OF MODAFINIL IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

DEVELOPMENT AND VALIDATION OF A SENSITVE RP-HPLC METHOD FOR ANALYSIS OF MODAFINIL IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

A simple, rapid, accurate, sensitive and cost-effective reversed-phase high-performance liquid chromatography (RP-HPLC-PDA) method for the analysis of Modafinil (MOD) in bulk and tablet formulations were developed. A C18 reverse phase column (Devlosil) of 250×4.6mm dimensions and 5?m particle size with the mobile phase containing Water: Acetonitrile (50:50 v/v) was used at a flow rate of 1 mL/min and the eluents were monitored at 230 nm. The optimized conditions showed a good linear response from 5 to 30?g/mL, with a regression coefficient (R2) of 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) were 0.2 and 0.7?g/mL, and the percentage recovery and assay were found to be 99.53 and 98.20. Specificity with placebo by 3 D plots showed that the method was specific and free from interfering substances. Therefore, the fully validated method was good enough to carry out routine analysis of MOD in bulk and tablet formulations with high sensitivity, less consumption of organic phase when compared to other published methods