DEVELOPMENT AND VALIDATION OF GREEN HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND LINAGLIPTIN IN COMBINED DOSAGE FORM

Document Type : Original Article

Authors

1 Department of Pharmaceutical Quality Assurance, Pioneer Pharmacy College, Vadodara, (Gujarat) India

2 Pioneer Pharmacy College

Abstract

A simple, accurate, rapid, sensitive and green high performance thin layer chromatography (HPTLC) technique was developed for the simultaneous determination of Dapagliflozin (DAPA) and Linagliptin (LINA) in pure and pharmaceutical dosage form. Chromatographic separation of both the drugs was performed on precoated silica gel aluminium plate 60 F 254, (10 X 10), 100 μm thickness; using the solvent system chloroform: methanol: ethyl Acetate: 1 % formic acid (3:4:3:0.5, v/v). Short-wave ultraviolet light at 224 nm was used to view the chromatographic bands. The proposed technique revealed compact bands with retention factor (Rf) values of 0.66 and 0.20, for DAPA and LINA, respectively. Calibration curves were polynomial in the concentration range of 3000-9000 ng/band for DAPA and 1500-4500 ng/band for LINA, with correlation coefficients of 0.995 and 0.996, respectively. The proposed method was validated with respect to ICH guideline. Green assessment of the developed HPTLC method was assessed using different green analytical chemistry metrics such as Analytical GREEness (AGREE), and Green Analytical Procedure Index (GAPI). The proposed method was applied for the analysis of drug in tablet formulation, and it can be used for routine quality control analysis.

Keywords

Bulletin of Pharmaceutical Sciences Assiut University
Volume 47, Issue 2
December 2024
Pages 1037-1048

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