Vol. 6, Issue 5 (2017)

Author(s):
Imad Osman Abu Reid

Abstract:
A rapid and specific normal phase high-performance liquid chromatographic method has been developed for the determination of metformin hydrochloride and its related impurities in raw material. Elution was performed on a silica column with acetonitrile: 0.05 M dipotassium hydrogen phosphate (20:80% v/v), adjusted to pH 7.0 as mobile phase. The influence of the various experimental parameters on the peaks separation has been studied and the optimum chromatographic conditions were concluded from the results of optimization studies. The linearity and limit of quantitation (LOQ) of the method for the parent drug and related impurities have been determined.