Development and Validation of a Method for Simultaneous Determination of Metformin and Saxagliptin in a Formulation by RP-HPLC  

作　　者：P. B. N. Prasad K. Satyanaryana G. Krishnamohan 

机构地区：[1]Central Drugs Testing Laboratory, CDSCO, Hyderabad, India [2]NATCO Pharma R&D, Hyderabad, India [3]Deparment of Pharmacy, JNTUH, Hyderabad, India

出　　处：《American Journal of Analytical Chemistry》2015年第11期841-850,共10页美国分析化学（英文）

摘　　要：A simple, specific, sensitive, precise and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) was developed for the simultaneous analysis of Metformin and Saxagliptin in active pharmaceutical ingredients (APIs) as well as in marketed tablet (combination) dosage forms. The method was achieved on Enable C18 G (250 × 4.6 mm;5 μm particle size) column using 0.05 M KH2PO4 buffer (pH 4.5):Methanol:Acetonitrile (60:20:20 %v/v) as a mobile phase at a flow rate of 0.6 mL/min and by employing UV detection at 220 nm wavelength. The retention time of Metformin and Saxagliptin were found to be 4.38 min and 6.92 min, respectively. The method was validated as per ICH guidelines. The limit of detection (LOD) and limit of quantification (LOQ) of Metformin were found to be 0.112 μg/mL and 0.373 μg/mL, respectively, while those of Saxagliptin were found to be 0.029 μg/mL and 0.096 μg/mL, respectively. The method was found to be rapid, sensitive, linear, specific, accurate, precise and economic for the quality control and stability assays of Metformin and Saxagliptin in marketed tablet dosage forms.A simple, specific, sensitive, precise and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) was developed for the simultaneous analysis of Metformin and Saxagliptin in active pharmaceutical ingredients (APIs) as well as in marketed tablet (combination) dosage forms. The method was achieved on Enable C18 G (250 × 4.6 mm;5 μm particle size) column using 0.05 M KH2PO4 buffer (pH 4.5):Methanol:Acetonitrile (60:20:20 %v/v) as a mobile phase at a flow rate of 0.6 mL/min and by employing UV detection at 220 nm wavelength. The retention time of Metformin and Saxagliptin were found to be 4.38 min and 6.92 min, respectively. The method was validated as per ICH guidelines. The limit of detection (LOD) and limit of quantification (LOQ) of Metformin were found to be 0.112 μg/mL and 0.373 μg/mL, respectively, while those of Saxagliptin were found to be 0.029 μg/mL and 0.096 μg/mL, respectively. The method was found to be rapid, sensitive, linear, specific, accurate, precise and economic for the quality control and stability assays of Metformin and Saxagliptin in marketed tablet dosage forms.

关 键 词：METFORMIN SAXAGLIPTIN SIMULTANEOUS Analysis RP-HPLC Stress Induced DEGRADATION 

分 类 号：R73[医药卫生—肿瘤]