STABILITY INDICATING RP HPLC METHOD FOR THE ESTIMATION OF ARMODAFINIL IN TABLET DOSAGE FORM
Keywords:Armodafinil, RP HPLC, Stability indicating assay, Validation
Objective: To develop simple reverse phase HPLC method for the estimation of Armodafinil in tablet dosage form.
Methods: Chromatography was performed by isocratic elution on a Stainless steel Hibar C18 column with dimensions 4.6 x 250 mm, packed with octadecylsilane bonded to porous silica (C18) with particle size 5 micron. Acetonitrile and water in the ratio of 50:50 v/v is used as mobile phase. The flow rate is 1.0 ml/ min and effluent is monitored at 220 nm. Armodafinil was eluted at a retention time of 3.8 minutes.
Results: The standard curve of Armodafinil was linear over a working range of 1â€“700 Âµg/ml and gave an average correlation coefficient of 0.999. The limit of quantitation (LOQ) of the drug is 0.1 Âµg/ ml. Recovery studies were carried out by standard addition method and the recoveries are found satisfactory within the range of 99.3 to 101.5 %. The method is precise with % RSD below
Conclusion: The method is validated in terms of robustness and forced degradation studies were carried out and this method can be applied for routine degradation studies ans quantification in regular laboratories.
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