Literature DB >> 35221267

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

Aqeela Raza1, Syed Hassan Murtaza1, Sana Hanif2, Javed Iqbal1, Ijaz Ali2, Tayyaba Aftab2, Rouheena Shakir2, Rushda Bedar2, Muhammad Ali Syed2.   

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 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⌖ 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 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 (<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.

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Year:  2022        PMID: 35221267

Source DB:  PubMed          Journal:  Pak J Pharm Sci        ISSN: 1011-601X            Impact factor:   0.684


  1 in total

1.  Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Metformin Hydrochloride in Tablet Dosage Forms by HPLC.

Authors:  Mousa Sha'at; Adrian Florin Spac; Iulian Stoleriu; Alexandra Bujor; Monica Stamate Cretan; Mihaela Hartan; Lacramioara Ochiuz
Journal:  Pharmaceutics       Date:  2022-05-31       Impact factor: 6.525

  1 in total

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