STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF METFORMIN AND ERTUGLIFLOZIN BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY WITH PDA DETECTION AND ITS APPLICATION TO TABLET DOSAGE FORM
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2019, Vol 12, Issue 3
Abstract
Objective: A sensitive, rapid, accurate, and precise stability indicating high-performance liquid chromatography method was developed and validated for the simultaneous estimation of metformin (MET) and ertugliflozin (ERT). Methods: The planned chromatographic method was developed using Kromasil C18 column using 0.1 M sodium dihydrogen phosphate methanol (50:50, by volume, pH 4.0) as mobile phase system followed by peak area response measurement at 238 nm. The developed method was validated by means of ICH guidelines about system suitability, linearity, sensitivity, selectivity, accuracy, precision, robustness, and specificity. Results: Calibration curves of MET and ERT are linear from 250 to 750 μg/ml and 3.75 to 11.25 μg/ml, respectively. Relative standard deviation is <2.0% and recovery is ̴ 100%. Successfully, the developed method was applied for the simultaneous determination of MET and ERT in tablets and to study degradation of MET and ERT in acidic, alkaline, oxidation, thermal, and photolytic degradation conditions. No obstructions from additional common excipients of tablets and degradants were observed. Conclusion: The results recommended method suitability for the analysis of MET and ERT in quality control laboratories.
Authors and Affiliations
KADALI JAGADEESH, ANNAPURNA N
Keywords
Related Articles
- EP ID EP603886
- DOI -
- Views 111
- Downloads 0
DARAPLADIB INHIBIT ADHESION MOLECULE EXPRESSION IN AORTA AT EARLY STAGES OF ATHEROSCLEROSIS USING SPRAGUE-DAWLEY TYPE 2 DIABETES MELLITUS MODEL
Objective: Hyperglycemia and hyperlipidemia in diabetes mellitus (DM) can lead an atherosclerosis. The increase of low-density lipoprotein level in DM and atherosclerosis is correlated with lipoprotein-associated phospho...
PHYTOCHEMICAL SCREENING, ANTIMICROBIAL, AND ANTIOXIDANT ACTIVITIES OF ROOT AND LEAF EXTRACTS OF LEUCAS ASPERA
Objective: The present study was designed to evaluate the phytochemical screening, antimicrobial, and antioxidant activities from the roots and leaves of Leucas aspera. Methods: The phytochemical screening and Fourier t...
A REVIEW: A GREEN APPROACH FOR THE SYNTHESIS OF SILVER NANOPARTICLES AND ITS ANTIBACTERIAL APPLICATIONS
  This review is based on the synthesis of silver nanoparticles (AgNPs) using a green approach which is biofabricated from various medicinal plants. AgNPs were prepared from the various parts of the plants such as the...
COMPARATIVE MUCOPENETRATION ABILITY OF METRONIDAZOLE LOADED CHITOSAN AND PEGYLATED CHITOSAN NANOPARTICLES
Objective: The objective of this study is to compare the mucopenetration ability of metronidazole loaded chitosan (CS) and pegylated CS nanoparticles.Methods: Nanoparticles were prepared by ionic gelation technique using...
PRELIMINARY MYCOCHEMICAL, GAS CHROMATOGRAPHY–MASS SPECTROSCOPY ANALYSIS, AND ANTIMICROBIAL PROPERTIES OF CALOCERA VISCOSA (PERS.) FR.
Objectives: Calocera viscosa, commonly called as the yellow stagshorn, is a jelly fungus, belongs to the family of Dacrymycetales, unknown for its medicinal properties and biological activities. Method: The sporocarps o...