Open AccessSTABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND DAPAGLIFLOZIN IN API AND PHARMACEUTICAL DOSAGE FORM
Author(s) -
Chaitali Dhale,
Rao J R
Publication year - 2021
Publication title -
international research journal of pharmacy
Language(s) - English
Resource type - Journals
ISSN - 2230-8407
DOI - 10.7897/2230-8407.1208157
Subject(s) - dapagliflozin , chromatography , metformin hydrochloride , dosage form , chemistry , acetonitrile , phosphoric acid , high performance liquid chromatography , hydrochloride , metformin , medicine , organic chemistry , type 2 diabetes , diabetes mellitus , endocrinology
A simple and specific stability indicating reversed-phase high-performance liquid chromatography technique has been developed and validated for the concurrent estimation of metformin hydrochloride and dapagliflozin in bulk and pharmaceutical dosage form. The ideal conditions were established for the study or analysis of the drug such as chromatographic separation was carried out on THERMO fisher ODS C18 column containing mobile phase of water and acetonitrile 65:35 % v/v of pH 6.8 adjusted with 0.1 % ortho phosphoric acid at a flow rate of 1 ml/minutes detected wavelength at 240 nm. The retention time was found to be 2.13 minutes and 5.41 minutes for metformin hydrochloride (MET) and dapagliflozin (DAPA) respectively. The proposed method was found to be linear in the concentration range of 100-600 ug/ml for MET (R2=0.9999) and 1-6 ug/ml for DAP (R2=0.9996), respectively. Method was validated according to ICH guidelines. Co-relation coefficients for both the drugs were found to be less than one. The mean % recoveries obtained were found to be 99.06-100.32% for metformin and 99.1-100.18% for dapagliflozin respectively. Stress testing is carried out for both drugs in acid, base, peroxide, photolytic and thermal degradation. The developed method can be effectively applied for routine analysis in simultaneous determination of metformin hydrochloride and dapagliflozin in bulk and combined tablet dosage form.