METHOD DEVELOPMENT AND STABILITY STUDY BY CHRO-MATOGRAPHIC METHOD FOR PERAMPANEL IN API AND TABLET DOSAGE FORM
Keywords:
HPLC, Perampanel, API, Tablet dosage form, OPA, TEAAbstract
To develop precise , accurate and reproducible stability assay method by RP-HPLC for estimation of Perampanel in API and Tablet dosage form.The adequate separation was carried using whatman ODS partisil column (250mm*4.6mm* 5?m) using ACN:Buffer (0.5 ml Triethylamine in 500 ml water adjust pH 2.5 with OPA) (60:40v/v).Detecting wavelength is 227 nm and Rt- 2.960 for API and 3.007 min for Tablet respectively.Linearity for Perampanel was found in the range of 50 -150 µg/ml (R2 = 0.99) respectively. The Accuracy of the present method was evaluated at 50 %,100% and 150%. The % recoveries of Perampanel API and Tablet were found to be in the range of 95.57 – 98.51 % and 94.57 – 97.57 % respectively. Precision studies were carried out and the RSD values were less than two. The method was found to be robust.The proposed method was found to be specific, accurate, precise and robust can be used for estimation of Perampanel in API and Tablet dosage form.
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