TY - JOUR AU - Sen, Dr. Dhanya B. PY - 2022/06/15 Y2 - 2024/03/28 TI - Simultaneous Assessment of Alogliptin Benzoate and Metformin Hydrochloride in Tablet Dosage Form by Reversed-phase High-performance Liquid Chromatography JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 16 IS - 2 SE - ORIGINAL ARTICLES DO - 10.22377/ajp.v16i2.4395 UR - http://www.asiapharmaceutics.info/index.php/ajp/article/view/4395 SP - AB - <p>Aim: A simple, accurate, precise, and sensitive reversed-phase high-performance liquid chromatography<br>(RP-HPLC) method was developed and validated for simultaneous assessment of alogliptin benzoate<br>(ALO) and metformin hydrochloride (MET) in combined tablet formulation. Materials and Methods: The<br>proposed RP-HPLC method employed a reverse phase column (C18) and mobile phase with a composition<br>of 0.2% (v/v) triethylamine (pH 5.5 with orthophosphoric acid) and methanol (2:98, v/v) was utilized and a<br>flow rate of1 mL min-1 was employed. Results and Discussion: Quantification of effluents was monitored<br>at 236 nm. Three symmetrical well resolved peaks of alogliptin, metformin, and benzoic acid (benzoic acid<br>was separated from ALO) were obtained with retention time of 4.730 ± 0.0267, 6.109 ± 0.0301, and 2.281 ±<br>0.0324 min, respectively. Both, alogliptin and metformin, showed excellent linearity over the concentration<br>range of 0.5–50 μg mL-1. The developed method was, then, validated in accordance with ICH guidelines and<br>applied in the determination of ALO and MET in the combined tablet dosage form. The formulation analysis<br>revealed good agreement (98–100% w/w) with the label claim for both the analytes by RP-HPLC method.<br>Conclusion: Developed method was simple, sensitive, and accurate which thus can be utilized for simultaneous<br>determination of both the drugs in combined tablet dosage form.</p> ER -