Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide
An efficient and simple HPLC method has been developed and validated for the simultaneous determination of gliclazide and metformin hydrochloride in bulk and was applied on marketed metformin and gliclazide products. The mobile phase used for the chromatographic runs consisted of 20 mM ammonium form...
| Main Authors: | , , |
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| Format: | Journal Article |
| Published: |
Elsevier Inc.
2018
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| Online Access: | http://hdl.handle.net/20.500.11937/70099 |
| _version_ | 1848762214678265856 |
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| author | Gedawy, A. Al-Salami, Hani Dass, Crispin |
| author_facet | Gedawy, A. Al-Salami, Hani Dass, Crispin |
| author_sort | Gedawy, A. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | An efficient and simple HPLC method has been developed and validated for the simultaneous determination of gliclazide and metformin hydrochloride in bulk and was applied on marketed metformin and gliclazide products. The mobile phase used for the chromatographic runs consisted of 20 mM ammonium formate buffer (pH 3.5) and acetonitrile (45:55, v/v) The separation was achieved on an Alltima CN (250 mm × 4.6 mm x5µ) column using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 227 nm. The method was linear at the concentration range 1.25–150 µg/ml for gliclazide and 2.5–150 µg/ml for metformin respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Metformin limit of detection (LOD) and limit of quantification (LOQ) were 0.8 µg/ml and 2.45 µg/ml respectively while LOD and LOQ for gliclazide were 0.97 µg/ml and 2.95 µg/ml respectively. |
| first_indexed | 2025-11-14T10:44:01Z |
| format | Journal Article |
| id | curtin-20.500.11937-70099 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T10:44:01Z |
| publishDate | 2018 |
| publisher | Elsevier Inc. |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-700992019-02-04T06:00:46Z Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide Gedawy, A. Al-Salami, Hani Dass, Crispin An efficient and simple HPLC method has been developed and validated for the simultaneous determination of gliclazide and metformin hydrochloride in bulk and was applied on marketed metformin and gliclazide products. The mobile phase used for the chromatographic runs consisted of 20 mM ammonium formate buffer (pH 3.5) and acetonitrile (45:55, v/v) The separation was achieved on an Alltima CN (250 mm × 4.6 mm x5µ) column using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 227 nm. The method was linear at the concentration range 1.25–150 µg/ml for gliclazide and 2.5–150 µg/ml for metformin respectively. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Metformin limit of detection (LOD) and limit of quantification (LOQ) were 0.8 µg/ml and 2.45 µg/ml respectively while LOD and LOQ for gliclazide were 0.97 µg/ml and 2.95 µg/ml respectively. 2018 Journal Article http://hdl.handle.net/20.500.11937/70099 10.1016/j.jfda.2018.06.007 http://creativecommons.org/licenses/by-nc-nd/4.0/ Elsevier Inc. fulltext |
| spellingShingle | Gedawy, A. Al-Salami, Hani Dass, Crispin Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title | Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title_full | Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title_fullStr | Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title_full_unstemmed | Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title_short | Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| title_sort | development and validation of a new analytical hplc method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide |
| url | http://hdl.handle.net/20.500.11937/70099 |