Quantitative analysis of gliclazide and glipizide in tablets by a new validated and stability-indicating RPTLC method

Abstract

A simple, rapid, and stability-indicating RPTLC method has been established and validated for quantitative analysis of two oral antidiabetic agents, the sulfonylureas gliclazide and glipizide, in tablets. Analysis was performed on RP-18 plates with 60% ( v/v ) acetonitrile in pH 2.3 phosphate buffer as mobile phase. Compact spots were obtained for gliclazide ( R F 0.38 ± 0.02, mean ± SD) and glipizide ( R F 0.51 ± 0.03). Detection and quantification were performed by classical densitometry at 215 nm, the wavelength of maximum absorption of gliclazide and glipizide. Calibration plots were constructed in the range 0.8–1.8 μg per 10 μL (per spot) for both drugs and were linear with good correlation coefficients ( r = 0.998 ± 0.001, mean ± SD, for gliclazide and r = 0.993 ± 0.002 for glipizide). The limits of detection and quantification were 50 and 200 ng per spot, respectively, for gliclazide and 60 and 300 ng for glipizide. The method was validated for robustness, precision, accuracy, stability, and specif...