HPTLC Determination of Three Gliptins in Binary Mixtures with Metformin.

Abstract

A single, simple, selective and validated high performance thin layer chromatographic (HPTLC) method was developed for the determination of either linagliptin (LGP), saxagliptin (SGP) or vildagliptin (VGP) in their binary mixtures with metformin (MET) in pharmaceutical preparations using environmentally preferable green mobile phase system. Separation was carried out on Merck HPTLC aluminum sheets of silica gel 60 F254 using methanol-0.5% w/v aqueous ammonium sulfate (8 : 2, v/v) as mobile phase. Densitometric measurement of the spots was performed at 225 nm for LGP/MET mixture and at 208 nm for both SGP/MET and VGP/MET mixtures. The linear regression analysis data were used for the regression line in the range of 0.05-0.5 µg/band for LGP and SGP and 0.2-2 and 5-40 µg/band for VGP and MET, respectively. The method was validated and showed good performances in terms of linearity, limits of detection and quantitation, precision, accuracy, selectivity and specificity. The calculated percentage relative error values and percentage relative standard deviation for intra- and interday precision studies did not exceed 2%. The developed method was satisfactorily applied for the analysis of pharmaceutical preparations and proved to be specific and accurate for the quality control of the cited drugs in their dosage forms.