Development and validation of a novel stability indicating RP-UPLC method for simultaneous determination of nizatidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation

摘要

A selective and accurate stability-indicating gradient reverse phase ultra performance liquid chromatographic method has been developed and validated for the simultaneous determination of nizatidine, methylparaben and propylparaben in pharmaceutical oral liquid formulation. The separation was achieved on Acquity UPLC? HSS T3 1.8 μm column by using mobile phase containing a gradient mixture of solvent A (0.02 Mol L ~(-1) KH _2PO _4, pH 7.5)and B(60:40 v/v mixture of methanol and acetonitrile)at flow rate of 0.4 mL min ~(-1). Drug product was exposed to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.