Development and validation of RP-HPLC method for simultaneous estimation of metformin HCl and sitagliptin in bulk and its pharmaceutical formulations

Der Pharmacia Lettre

K. Pushpa Latha¹ 

关键词: K. Pushpa Latha;    D. Ramach;    ran;    Liquid Chromatography;    Metformin HCl;    Sitagliptin;    Combined dosage forms;    Simultaneous estimation;    Validation;   

DOI  :  

学科分类：药理学

来源: Scholars Research Library

【 摘 要 】

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for simultaneous estimation of Metformin HCl and Sitagliptin in tablet formulations. The separation was achieved by using ACE column C18 150 x 4.6 mm, 5.0 μm particle size, in mobile phase Orthophosphoric acid buffer and Methanol in the ratio of 600:400v/v. The flow rate was 1.0 mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 228 nm. The retention time of Metformin HCl, and Sitagliptin, was noted to be 3.00 and 4.50, respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

【 授权许可】

CC BY