A NEW METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PARACETAMOL IN PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Keywords:
Paracetamol, RP-HPLC, Isocratic, Retention time, ValidationAbstract
Objective: An accurate, simple, reproducible and sensitive method for the determination of paracetamol in pharmaceutical dosage form was developed and validated using a reversed-phase C18 column (250 mm X 4.6 mm i. d, 5 µm particle size) with isocratic elution.
Methods: A mixture of Acetonitrile: 10 mM potassium dihydrogen orthophosphate buffer (15:85 v/v), pH 2.5 was used as a mobile phase at the flow rate of 1.0 ml/min and detector wavelength at 210 nm. The retention time of paracetamol was found to be 5.7 minutes (min). The method was statistically validated for the linearity, accuracy, precision and robustness.
Results: The linearity of paracetamol was in the range of 25.00 to 60.00µg/ml. This method showed an excellent linear response with the correlation coefficient (R2) value of 0.999 for the paracetamol. The recovery of the drug was ranged from 99.51 to 100.68%. An intra-day and inter-day precision study of the new method was less than the maximum allowable limit (% RSD<2.0).
Conclusion: The proposed method was cost effective, which can be used for the estimation of paracetamol in bulk and in solid dosage forms.
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