Development and validation of new FTIR method for quantitative analysis of gliclazide in bulk and pharmaceutical dosage forms

摘要

A Fourier transform infrared (FTIR) spectrophotometric method was developed for quantitiative analysis of gliclazide in pharmaceutical formulations. The method involves extraction of gliclazide from tablets with chloroform by sonication and the direct measurement of the absorbance in liquid phase using a reduced path length cell. In general the IR spectrum was measured in transmission mode, for quantitation of gliclazide the spectra were measured in absorbance mode. The infrared spectrum of gliclazide shows peaks at 1650 cm~(-1), 3400cm~(-1), 3000 cm~(-1) corresponding to the carbonyl group, N-H group, and C-H group respectively. Among which N-H group showed intense, clear peak which is selected for quantitative estimation of gliclazide. The method was validated as per ICH guidelines. The results obtained were compared statistically with the existing HPLC method by t-test which indicated there is no significant difference between the methods at the probability value 0.05. The results demonstrated that the proposed method is accurate, precise while being simple and rapid tool for the determination of gliclazide in bulk and tablet dosage forms.