Abstract
Objective: A new, simple, rapid, sensitive, and accurate stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative determination of linagliptin (LNG) and empagliflozin (EMP) in pure and tablet dosage forms.
 Methods: An isocratic HPLC method, using a C18 reversed-phase column (150 mm×4.6 mm i.d., particle size 5 μm) with an isocratic binary mobile phase consisting of phosphate buffer and acetonitrile (65:35, v/v), was investigated to separate the drug from its stress degradation products. The flow rate was 1.0 mL/min at ambient temperature and photodiode array detector is used at 226 nm for detection. The developed method was validated for system suitability, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness.
 Results: The retention time of LNG and EMP was found to be 3.276±0.002 and 6.966±0.0006 min, respectively. The calibration curve was found to be linear with the equation y=158926.39X+11.139, with a correlation coefficient of R2=0.9991 for LNG and y=22688.45X+4.259, with a correlation coefficient of R2=0.9994 for EMP over a concentration range of 2.5–7.5 μg/mL and 5.0–15 μg/mL for LNG and EMP, respectively. The limits of detection were 0.29 and 0.48 μg/mL for LNG and EMP, respectively, and the limits of quantification were 0.89 and 1.5 μg/mL for LNG and EMP, respectively. The recovery values of this method are 101.11% and 101.48% for LNG and EMP, respectively, and the reproducibility is within 0.070 and 0.277 for LNG and EMP, respectively.
 Conclusion: The proposed method is a rapid stability-indicating HPLC method that can be applied for the determination of LNG and EMP in pure and tablet dosage forms.
Highlights
Linagliptin (LNG) is a more potent dipeptidyl peptidase (DPP)-4 inhibitor than other drugs that belong to the same class for the treatment of Type II diabetes
LNG is a competitive and reversible DPP-4 enzyme inhibitor that slows the breakdown of insulinotropic hormone glucagon-like peptide-1 for better glycemic control in diabetes patients
Empagliflozin (EMP) is a sodium glucose cotransporter-2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes
Summary
Linagliptin (LNG) is a more potent dipeptidyl peptidase (DPP)-4 inhibitor than other drugs that belong to the same class for the treatment of Type II diabetes. LNG is a competitive and reversible DPP-4 enzyme inhibitor that slows the breakdown of insulinotropic hormone glucagon-like peptide-1 for better glycemic control in diabetes patients. Empagliflozin (EMP) is a sodium glucose cotransporter-2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes. The combination of LNG and EMPis served as an adjuvant to diet and exercise to improve glycemia control in adults with Type-2 diabetes who know to have the cardiovascular disease [1,2,3].LNGchemically,8-[(3R)-3-aminopiperidin-yl]-7-(but-2yn-1-yl)-3-. The aim of the present work is to develop and validate simple, fast, and reliable stability-indicating reverse-phase HPLC method with ultraviolet (UV) detection for the simultaneous determination of LNG and EMP in pure and pharmaceutical dosage forms.
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