Validation of a rapid and economical RP-HPLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate monohydrate: Greenness evaluation using AGREE score | [Pakistan Journal of Pharmaceutical Sciences • 2022]

Author(s):

1. Aqeela Raza: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, The University of Lahore,,Pakistan

2. Syed Hassan Murtaza: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, The University of Lahore,,Pakistan

3. Sana Hanif: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

4. Javed Iqbal: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, The University of Lahore,,Pakistan

5. Ijaz Ali: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

6. Tayyaba Aftab: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

7. Rouheena Shakir: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

8. Rushda Bedar: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

9. Muhammad Ali Syed: Department of Pharmaceutics, Faculty of Pharmacy, The University of Lahore,,Pakistan

Abstract:

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 ecofriendly HPLC method for synchronized analysis of both drugs was aimed to develop and validate in current study. Analytical evaluation was executed on Shimadzou® C18 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 25oC. 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 (<0.8). Conclusively, the developed method was time saving, economical, rapid, robust, rugged, precise, accurate and found to be applicable for simultaneous determination of MET and SIT in commercial tablets.

Page(s): 15-21

DOI: 10.36721/PJPS.2022.35.1.REG.015-021.1

Published: Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 35, Issue: 1, Year: 2022

Keywords:

RPHPLC , Metformin , Sitagliptin , ICH guidelines , method development and validation

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