Abstract

A selective and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Metformin and Alogliptin 10 mg of Metformin and Alogliptin was dissolved in mobile phase. The solution was scanned from 200-400 nm the spectrum was obtained. The overlay spectrum was used for selection of wavelength for Metformin and Alogliptin. The isobestic point was taken as detection wavelength. 25 mg of metformin working standard was accurately weighed and transferred into a 10 ml clean dry volumetric flask and add about 1 ml of diluent and sonicated to dissolve it completely and make volume up to the mark with the same solvent (Stock solution).Further pipette out 1 ml from the above stock solution into a 10 ml volumetric flask and was diluted up to the mark with diluent. 10L of the blank, standard and sample were injected into the chromatographic system and areas for the Metformin and Alogliptin the peaks were used for calculating the % assay by using the formulae. The system suitability parameters for metformin and Alogliptin such as theoretical plates and tailing factor were found to be 2294, 1.27 and 4891 and 1.03, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of metformin and Alogliptin was found in concentration range of 50μg-250μg and 5μg-25μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.7and 0.8, % RSD for intermediate precision was 0.10 and 0.5 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.

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