Stability-indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form
© 2020 John Wiley & Sons, Ltd..
A rapid stability-indicating reversed phase-ultrapure liquid chromatography (RP-UPLC) was developed and validated for the estimation of metformin (MET), linagliptin (LIN), and empagliflozin (EMP) combination in bulk and tablet dosage form using Kromasil C18 column (2.1 × 50 mm, 1.8 μm) as a stationary phase and a mixture solution of 40% phosphate buffer (pH = 3) and 60% acetonitrile as mobile phase at a flow rate of 0.6 mL/min. The detection was performed at 248 nm using a photodiode array detector. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were determined. The peak area response-concentration curve was rectilinear over the range of 50-150 (MET), 5-15 (LIN), and 10-30 μg/mL (EMP) with quantitation limits of 0.042 (MET), 0.023 (LIN), and 0.059 μg/mL (EMP). The proposed method was successfully validated for the determination of MET, LIN, and EMP simultaneously in combined tablet dosage form. The performance of the proposed method was compared with reported RP-UPLC methods and found to be rapid and economical. The developed and validated stability-indicating RP-UPLC method was appropriate for the quality control and drug analysis.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Biomedical chromatography : BMC - 35(2021), 4 vom: 16. Apr., Seite e5019 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Vankalapati, Krishna Rao [VerfasserIn] |
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| Links: |
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| Themen: |
3X29ZEJ4R2 |
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| Anmerkungen: |
Date Completed 28.06.2021 Date Revised 28.06.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/bmc.5019 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM317146718 |
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| 245 | 1 | 0 | |a Stability-indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 John Wiley & Sons, Ltd. | ||
| 520 | |a A rapid stability-indicating reversed phase-ultrapure liquid chromatography (RP-UPLC) was developed and validated for the estimation of metformin (MET), linagliptin (LIN), and empagliflozin (EMP) combination in bulk and tablet dosage form using Kromasil C18 column (2.1 × 50 mm, 1.8 μm) as a stationary phase and a mixture solution of 40% phosphate buffer (pH = 3) and 60% acetonitrile as mobile phase at a flow rate of 0.6 mL/min. The detection was performed at 248 nm using a photodiode array detector. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were determined. The peak area response-concentration curve was rectilinear over the range of 50-150 (MET), 5-15 (LIN), and 10-30 μg/mL (EMP) with quantitation limits of 0.042 (MET), 0.023 (LIN), and 0.059 μg/mL (EMP). The proposed method was successfully validated for the determination of MET, LIN, and EMP simultaneously in combined tablet dosage form. The performance of the proposed method was compared with reported RP-UPLC methods and found to be rapid and economical. The developed and validated stability-indicating RP-UPLC method was appropriate for the quality control and drug analysis | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a RP-UPLC | |
| 650 | 4 | |a empagliflozin | |
| 650 | 4 | |a linagliptin | |
| 650 | 4 | |a metformin | |
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| 650 | 4 | |a tablet dosage form | |
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| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
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| 700 | 1 | |a Boodida, Sathyanarayana |e verfasserin |4 aut | |
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