Stability-indicating HPLC-DAD method for the determination of empagliflozin
Abstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm abso...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2021-08-01
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| Series: | Future Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43094-021-00329-w |
| _version_ | 1818732995489562624 |
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| author | Shilpi Pathak Pradeep Mishra |
| author_facet | Shilpi Pathak Pradeep Mishra |
| author_sort | Shilpi Pathak |
| collection | DOAJ |
| description | Abstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Results Calibration curve plot was found within the range of 10–50 µg/mL. The coefficient of determination (R 2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. Conclusion The method was validated as per ICH guidelines with respect to all validation parameters. |
| first_indexed | 2024-12-17T23:42:26Z |
| format | Article |
| id | doaj.art-79d73ec74f2545a78e34094e1510b0b0 |
| institution | Directory Open Access Journal |
| issn | 2314-7253 |
| language | English |
| last_indexed | 2024-12-17T23:42:26Z |
| publishDate | 2021-08-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Future Journal of Pharmaceutical Sciences |
| spelling | doaj.art-79d73ec74f2545a78e34094e1510b0b02022-12-21T21:28:24ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532021-08-01711810.1186/s43094-021-00329-wStability-indicating HPLC-DAD method for the determination of empagliflozinShilpi Pathak0Pradeep Mishra1Institute of Pharmaceutical Research, GLA UniversityInstitute of Pharmaceutical Research, GLA UniversityAbstract Background A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Results Calibration curve plot was found within the range of 10–50 µg/mL. The coefficient of determination (R 2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. Conclusion The method was validated as per ICH guidelines with respect to all validation parameters.https://doi.org/10.1186/s43094-021-00329-wEmpagliflozinRP-HPLCStress studyValidationDAD detector |
| spellingShingle | Shilpi Pathak Pradeep Mishra Stability-indicating HPLC-DAD method for the determination of empagliflozin Future Journal of Pharmaceutical Sciences Empagliflozin RP-HPLC Stress study Validation DAD detector |
| title | Stability-indicating HPLC-DAD method for the determination of empagliflozin |
| title_full | Stability-indicating HPLC-DAD method for the determination of empagliflozin |
| title_fullStr | Stability-indicating HPLC-DAD method for the determination of empagliflozin |
| title_full_unstemmed | Stability-indicating HPLC-DAD method for the determination of empagliflozin |
| title_short | Stability-indicating HPLC-DAD method for the determination of empagliflozin |
| title_sort | stability indicating hplc dad method for the determination of empagliflozin |
| topic | Empagliflozin RP-HPLC Stress study Validation DAD detector |
| url | https://doi.org/10.1186/s43094-021-00329-w |
| work_keys_str_mv | AT shilpipathak stabilityindicatinghplcdadmethodforthedeterminationofempagliflozin AT pradeepmishra stabilityindicatinghplcdadmethodforthedeterminationofempagliflozin |