Development and validation of reversed phase high performance liquid chromatographic method for determination of moxonidine in the presence of its impurities

A simple, rapid, isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the analysis of moxonidine and its impurities in tablet formulations. The chromatographic separation was achieved on a Symmetry shield C18 column (250 mm × 4.6 mm, 5 μm) by employing a mobile phase consisting of methanol–potassium phosphate buffer (0.05 M) mixture (15:85, v/v) (pH 3.5) at a flow rate of 1 ml min−1; detection at 255 nm. Central composite design technique and response surface method were used to evaluate the effects of variations of selected factors (buffer pH value, column temperature, methanol content) in order to achieve the best isocratic separation within short analysis time (less than 10 min), as well as for robustness test considerations. The method fulfilled the validation criteria: specificity, linearity, accuracy, precision, limit of detection and limit of quantitation. The method was successfully applied for the analysis of commercial moxonidine tablets.

► Moxonidine is a second-generation centrally acting antihypertensive drug.
► An isocratic RP–HPLC method was developed for the analysis of moxonidine and its impurities.
► Central composite design and response surface methodology were used as statistical tools.
► Statistical tools were applied in method development and robustness testing.