ABSTRACT

A simple, rapid, sensitive & selective stability indicating RP-HPLC method is developed for the determination of anagliptin and Metformin HCL in tablet dosage form. A RP-HPLC analysis was performed on KROMASIL C18 column and its size 250×4.6mm, 5?m with using mobile phase methanol and 0.05M potassium dihydrogen phosphate with buffer pH4 in ratio (30:70) at 220nm detection wavelength. The gradient was optimized with flow rate 1 mL/min. the completed analytical method validation was successfully carried out as per ICH guidelines. The recovery study was carried out at 80% ,100% and 120% level of working concentration and result were in the range 100.1-101.2% for Metformin HCL and 100.2- 100.9% for Anagliptin. The linearity was proven in concentration range 5-15?g/mL for anagliptin and 25- 75?g/mL for Metformin HCL. The limit of detection (LOD) was found to be 0.069?g/mL for anagliptin & 1.56?g/mL for metformin HCL. The LOQ value was found to be 0.209?g/mL for anagliptin & 4.716?g/mL for metformin HCL. All validation parameters was in accepted range as per ICH guideline. furthermore, forced degradation study was also performed at various stress condition such as acidic, basic, oxidative and photolytic as per protocol of ICH. The developed method can be successfully used for the estimation of Anagliptin & Metformin HCL in tablet dosage form. Keywords: Anagliptin, Metformin HCL, stability indicating RP-HPLC method, validation
Publication date: 01/09/2024

https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8293.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.9.8293