Determination of Alogliptin Benzoate and Metformin Hydrochloride in Tablet Dosage Form by Simultaneous Equation and Absorption Ratio Method

Abstract

Objective: Development and validation of two simple, rapid, accurate and sensitive UV-spectrophotometric methods for simultaneous estimation of alogliptin benzoate (ALO) and metformin hydrochloride (MET) in bulk and tablet dosage form. Methods: First method (Method A) is simultaneous equation method, which is based on the measurement of absorption at 224 nm and 237 nm for both ALO and MET, respectively. Second method (Method B) is an absorption ratio method, which is based on the measurement of absorption at 251 nm i.e. Iso-absorptive point of ALO and MET and 224 nm which is λmax of ALO. Results: Both the drugs were found to be linear in the concentration range of 0.5-18 μg/ml and correlation co-efficient was found to be 0.9998 and 0.9992 for ALO and 0.9998 and 1 for MET at 224 nm and 237 nm, respectively for simultaneous equation method. For absorption ratio method, both the drugs were found to be linear in the concentration range of 0.5-18 μg/ml and correlation co-efficient was found to be 0.9998 and 0.9997 for ALO and 0.9998 and 0.9997 for MET at 224 nm and 251 nm, respectively. Recovery studies at 50, 100 and 150% levels were carried out to assess accuracy of the methods. Precision studies were also carried out and %RSD was found to be within the limit (% RSD<2). The percentage assay (Method A) was found to be 100.57±1.1367 and 101.24±1.0936 for ALO and MET, respectively. For Method B, percentage assay was found to be 101.46±0.7160 for ALO and 100.15±0.6953 for MET. Conclusion: The developed methods were found to be simple, rapid, accurate and sensitive. Therefore, both the methods can be successfully applied for simultaneous determination of ALO and MET in tablet formulation.