Open AccessDevelopment and Validation of Modern UHPLC-DAD Analytical Method for Simultaneous Determination of Repaglinide and Metformin in Pharmaceutical Dosage Forms
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22915
Subject(s) - repaglinide , chemistry , metformin , dosage form , chromatography , phosphate buffered saline , metformin hydrochloride , acetonitrile , pharmaceutical formulation , diabetes mellitus , medicine , endocrinology
For the simultaneous determination of repaglinide and metformin hydrochloride in bulk, an effectiveand simple UHPLC method was developed and validated and applied to marketed repaglinide andmetformin products. The mobile phase used for chromatographic runs consisted of 30 mM phosphatebuffer (pH 3.7) and acetonitrile (20:80, v/v) separation was implemented using isocratic mode on anAgilent Zorbax Eclipse Plus C18 (150 × 4.6 mm, 5 μm) column. Drug peaks were well separated anda 232 nm DAD detector observed them. The method was linear for repaglinide and metformin at theconcentration range of 20-100 μg/mL, respectively. The method has been validated with respect tosystem suitability, specificity, accuracy, precision, robustness and ruggedness according to ICHguidelines. Repaglinide and metformin forced degradation studies were conducted for under acidic,base, neutral (peroxide), thermal and photo conditions.