Abstract :
A new RP-HPLC method for the quantitative determination of Flupiritine Maleate and Paracetamol was developed
and validated as per ICH guidelines. The drugs were injected into Azilent HPLC system with SPD-20A Detector and
C18 column (250×4.6, 5 µm) maintained at ambient temperature and effluent monitored at 240 nm. The mobile
phase consisted of 0.1% Orthophosphoric acid: Methanol (50:50 V/V). The flow rate was maintained at 1.0 ml/min.
The calibration curve for flupiritine maleate and paracetamol was linear from 6-300.03µg/ml and 1.25 - 60.08µg/ml
(r
2
for Flupiritine Maleate =1.0 and r
2
for Paracetamol = 0.99). The proposed method was adequate, sensitive,
reproducible, accurate and precise for the determination of Flupiritine Maleate and Paracetamol in bulk and
pharmaceutical dosage form.
Keywords: Flupiritine Maleate and Paracetamol, Linearity, Validation.
Keyword :
Flupiritine Maleate and Paracetamol, Linearity, Validation.