Validation of a rapid and economical RP-HPLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate monohydrate: Greenness evaluation using AGREE score

• Published in: Pakistan journal of pharmaceutical sciences 2022-01, Vol.35 (1), p.15-21
• Main Authors: Raza, Aqeela, Murtaza, Syed Hassan, Hanif, Sana, Iqbal, Javed, Ali, Ijaz, Aftab, Tayyaba, Shakir, Rouheena, Bedar, Rushda, Syed, Muhammad Ali
• Format: Article
• Language: English
• Subjects: Dosage and administration; High performance liquid chromatography; Metformin; Methods; Sitagliptin; Testing
• ISSN: 1011-601X
• DOI: 10.36721/PJPS.2022.35.1.REG.015-021.1

Reported high performance liquid chromatographic (HPLC) methods for estimating metformin hydrochloride (MET) and sitagliptin phosphate monohydrate (SIT) are either laborious or contain higher proportions of organic solvents in mobile phase, thus presenting exorbitant procedures. So, a rapid, significantly more economical and eco-friendly HPLC method for synchronized analysis of both drugs was aimed to develop and validate in current study. Analytical evaluation was executed on Shimadzou⌖ C column (250mm × 4.6mm, 5μm) using acidified water and methanol 60:40 (v/v) as mobile phase at a flow of 1mL/min; while peaks were detected at 260nm at 25°C. Resultant values of accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ), robustness and specificity depicted that the method was validated in accordance with the ICH Guidelines. The approximate retention time for MET and SIT were 1.96 and 3.70 min, correspondingly. The greenness score of the developed method was evaluated using AGREE software and was found better (0.81) as compared with the methods reported (