Determination of linagliptin and empagliflozin by UPLC and HPTLC techniques aided by lean six sigma approach
| Autor: | Ebrahim A. El-Desouky, Ayman O. E. Osman, Ashraf Abdel-Fattah, Ahmed M. Abdel-Raoof, Ahmed H. Abdel-Monem, Samir Morshedy, Ahmed M. Abdelzaher |
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| Rok vydání: | 2021 |
| Předmět: |
Analyte
Resolution (mass spectrometry) Clinical Biochemistry Linagliptin 030226 pharmacology & pharmacy 01 natural sciences Biochemistry High-performance liquid chromatography Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Glucosides Limit of Detection Drug Discovery Empagliflozin medicine Benzhydryl Compounds Lean Six Sigma Molecular Biology Chromatography High Pressure Liquid Pharmacology Isocratic elution Chromatography Chemistry 010401 analytical chemistry Phosphate buffered saline Reproducibility of Results General Medicine 0104 chemical sciences Linear Models Chromatography Thin Layer medicine.drug Tablets Total Quality Management |
| Zdroj: | Biomedical chromatography : BMCREFERENCES. 35(7) |
| ISSN: | 1099-0801 |
| Popis: | Two chromatographic techniques were developed and validated for simultaneous determination of the newly co-formulated antidiabetic combination linagliptin and empagliflozin in their pure form and film-coated tables. The first technique was UPLC; the separation and resolution of both analytes were achieved using a Zorbax eclipse plus C18 column applying an isocratic elution based on phosphate buffer pH 4-acetonitrile (65:35, v/v) as a running mobile phase at flow rate 1.5 ml/min and the effluent was monitored at 220 nm. Augmentation of Lean Six Sigma with UPLC and HPTLC methods had a major impact on the development of robust specifications to ensure that the quality at six sigma level has a high level of statistical confidence and target performance. On the chromatogram, empagliflozin and linagliptin appeared at retention times of 1.417 and 2.453 min, respectively. The second technique was HPTLC; both analytes were fairly well resolved and separated using a developing mobile phase composed of ethyl acetate-chloroform-acetonitrile (55:25:20 by volume). The values of retention factor (RF ) were 0.29 and 0.53 for linagliptin and empagliflozin, respectively. All variables were investigated to adjust the whole conditions. |
| Databáze: | OpenAIRE |
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