Simultaneous Estimation of Empagliflozin and Linagliptin in Bulk and Pharmaceutical Dosage Form by Reverse Phase-High Performance Liquid Chromatography

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Autore principale: Divya Jyothi*, Dr. S. Shobha Rani
Natura: Recurso digital
Pubblicazione: Zenodo 2025
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author Divya Jyothi*, Dr. S. Shobha Rani
author_facet Divya Jyothi*, Dr. S. Shobha Rani
contents <p><span lang="EN-US">A new, simple, precise, rapid, selective and stability reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous quantification of Empagliflozin and Linagliptin in pure form and its pharmaceutical dosage form. The method is based on Phenomenex Gemini C18 (4.6×250mm) 5µ column. The column is maintained at 40°C throughout the analysis. The total run time is about 10 min. The method is validated for specificity, accuracy, precision and linearity, robustness and ruggedness, system suitability, limit of detection and limit of quantitation as per international conference of harmonization (ICH) Guidelines. inter-day precision (<2%) and robustness. The advantages of this method are good resolution with sharper peaks and sufficient precision. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations.</span></p>
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id zenodo_https___doi_org_10_5281_zenodo_17515692
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publishDate 2025
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spellingShingle Simultaneous Estimation of Empagliflozin and Linagliptin in Bulk and Pharmaceutical Dosage Form by Reverse Phase-High Performance Liquid Chromatography
Divya Jyothi*, Dr. S. Shobha Rani
Empagliflozin and Linagliptin; Tablet doage forms; RP-HPLC; UV-VIS Detection; ICH Guidelines.
<p><span lang="EN-US">A new, simple, precise, rapid, selective and stability reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous quantification of Empagliflozin and Linagliptin in pure form and its pharmaceutical dosage form. The method is based on Phenomenex Gemini C18 (4.6×250mm) 5µ column. The column is maintained at 40°C throughout the analysis. The total run time is about 10 min. The method is validated for specificity, accuracy, precision and linearity, robustness and ruggedness, system suitability, limit of detection and limit of quantitation as per international conference of harmonization (ICH) Guidelines. inter-day precision (<2%) and robustness. The advantages of this method are good resolution with sharper peaks and sufficient precision. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations.</span></p>
title Simultaneous Estimation of Empagliflozin and Linagliptin in Bulk and Pharmaceutical Dosage Form by Reverse Phase-High Performance Liquid Chromatography
topic Empagliflozin and Linagliptin; Tablet doage forms; RP-HPLC; UV-VIS Detection; ICH Guidelines.
url https://doi.org/10.5281/zenodo.17515692