STABILITY INDICATING HPLC. METOCLOPRAMIDE & PARACETAMOL IN COMBINE DOSAGE FORM

      Аннотация: A simple, precise and rapid stability-indicating HPLC assay method was developed for the simultaneous quantitative estimation of Paracetamol and Metoclopramide from their dosage form in the presence of degradation products. It involved 250 mm ? 2.5mm, 5?, hypersil, C18 column. The separation was achieved on simple gradient program. The mobile phase contains 7 ml of Triethylamine in 1000 ml of water, pH 4.0 + 0.02 adjusted with orthophosphoric acid and Methanol. The flow rate was maintained to 1 ml/min and column oven temperature was kept 25°C. The detector wavelength was 218 nm for Paracetamol and Metoclopramide. The retention time of Paracetamol and Metoclopramide was found to be 3.403 and 5.790 minutes respectively. The total runtime was 10.0 minutes within which two active compounds and their degradation products were separated. Acid, base, peroxide, thermal and photolytic degradation was carried out and significant degradation was achieved except thermal and photo degradation. The method was found to be specific enough to separate degradation products from main analytes.

Ключевые слова: HPLC, validation, Stability, degradation product