Development and Validation of Stability Indicating HPLC Method for Estimation of Metoclopramide Hydrochloride From A Novel Formulation

A new, simple, specific, precise and robust isocratic reversed-phase (RP) stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for determination of metoclopramide hydrochloride from a novel pellet formulation. The liquid chromatographic separation was achieved isocratically using a mobile phase of acetonitrile: water (25:75), with 0.06 % triethylamine and pH adjusted to 4 using orthophosphoric acid. The analysis was carried out using Hi-Q-Sil C18 column [250 mm x 4.6 mm, 5 μm] at flow rate of 1 ml/min and the UV detection at 274 nm. The method was validated for accuracy, precision, linearity, range, selectivity and robustness. The linearity of the proposed method was investigated in the range of 0.5–18 μg/ml (r2 = 0.9985). The drug was subjected to oxidation, hydrolysis, heat and photolysis to apply stress conditions. The method provided good peak parameters with retention time of 6.2 ± 0.02 min. Degradation products resulting from stress studies did not interfere with the detection of metoclopramide hydrochloride and the assay can thus be considered as stability-indicating.