A Rapid, Stability Indicating RP-UPLC Method for Determination of Paliperidone Palmitate in a Depot Injectable Formulation

Summary of method optimization . Experimental condition Observation Water(MP-A) and acetonitrile (MP-B), linear gradient; Acquity BEH-C8 (50 mm × 2.1 mm, 1.7 µm); 25°C PP peak was merged with impurity peak 0.01 M KH 2 PO 4 (MP-A) and acetonitrile (MP-B), linear gradient; Acquity BEH-C18 (50 mm × 2.1 mm, 1.7 µm); 25°C PP peak was merged with impurity peak 3.854 gm Ammonium acetate + 1.5 mL of triethylamine, pH 6.0 with Glacial acetic acid (buffer) and acetonitrile, (10:90) v/v; Acquity BEH-C18 (50 mm × 2.1 mm, 1.7 µm); 40°C PP peak was separated from impurities but found tailing [Figure 3] 3.854 gm Ammonium acetate + 3 mL of triethylamine, pH 4.5 with Glacial acetic acid (buffer) and acetonitrile, (10:90) v/v; Acquity BEH-C18 (50 mm × 2.1 mm, 1.7 µm); 50°C Satisfactory peak separation and peak shape Analytical parameters and validation After development, this method was subjected to validation according to ICH guidelines [6]. The method was validated to demonstrate that it is suitable for its intended purpose by the standard procedure to evaluate adequate validation characteristics (system suitability, accuracy, precision, linearity, robustness, solution stability and stability-indicating capability).