Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation.
New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, British University in Egypt (BUE), El-Sherouk City, Cairo 11837, Egypt; The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, British University in Egypt (BUE), El-Sherouk City, Cairo 11837, Egypt. Electronic address: bassam.ayoub@bue.edu.eg.
Bassam M
BM
Ayoub
D001559:Benzhydryl Compounds / Q000032:analysis*; D005960:Glucosides / Q000032:analysis*; D007004:Hypoglycemic Agents / Q000032:analysis*; D016018:Least-Squares Analysis; D057230:Limit of Detection; D008687:Metformin / Q000032:analysis*; D013053:Spectrophotometry / Q000379:methods*; D013607:Tablets
D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; D013607:Tablets; D008687:Metformin; C570240:empagliflozin
Chemometry; Empagliflozin; Metformin; Partial least squares; Pharmaceutical preparation; Simultaneous equation