ABSTRACT

Objective: A method for HPTLC was developed and validated for simultaneous estimation of Alogliptin benzoate and Metformin HCl in a pharmaceutical dosage form. Method: The Chromatographic separation was achieved on TLC aluminum plates precoated with silica gel G60 F254 as the stationary phase. The mobile phase consisted of Methanol: Tetrahydrofuran: Ammonium formate in the ratio of 3:5.5:2.5 v/v/v. Results: The method was found to be linear in the concentration range of 0.225-1.12µg/spot for ALG and 9-45 µg/spot for MET and the correlation coefficient were found to be 0.998 for ALG and 0.992 for MET. The % RSD values were found to be within the acceptance criteria, the low % RSD indicates that proposed method is precise as per ICH guidelines. The accuracy of the method was determined and the mean recovery of ALG was 99.25-101.35% and MET was 100.49- 101.79%. LOD and LOQ values were found to be 0.002 µg/spot and 0.05 µg/spot for ALG, 0.04µg/spot and 0.1 µg/spot for MET. Conclusion: The method reported is accurate, precise, specific, robust and linear for the estimation of Alogliptin and Metformin in Pharmaceutical dosage form. Keywords: Alogliptin, Metformin, HPTLC, Chromatography, ICH
Publication date: 01/10/2022

https://ijbpas.com/pdf/2022/October/MS_IJBPAS_2022_6521.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.10.6521