PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET
Metformin is a polar compound if analyzed by reversed-phase of HPLC will appear in a fast retention time, this complicates the determination of metformin in plasma due to be overlapping between metformin peak compound with endogenous peak compounds in plasma. To solve it, ion pairing reagent sodium...
| Main Authors: | , |
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| Format: | Thesis |
| Published: |
[Yogyakarta] : Universitas Gadjah Mada
2014
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| Subjects: |
| _version_ | 1797035953180639232 |
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| author | , SISKA RUSMALINA , Dr, RR. Endang Lukitaningsih, M.Si., Apt |
| author_facet | , SISKA RUSMALINA , Dr, RR. Endang Lukitaningsih, M.Si., Apt |
| author_sort | , SISKA RUSMALINA |
| collection | UGM |
| description | Metformin is a polar compound if analyzed by reversed-phase of HPLC
will appear in a fast retention time, this complicates the determination of
metformin in plasma due to be overlapping between metformin peak compound
with endogenous peak compounds in plasma. To solve it, ion pairing reagent
sodium dodesil sulfate (SDS) is used. The purpose of this study is to develop and
validate the analytical methods metformin assay in spiked human plasma and
tablet dosage form by HPLC using a reversed-phase column Supelco Ascentis®
Phenyl (length 250 mm, internal diameter 4.6 mm, particle size 5μm).
HPLC system consisted of a reversed-phase column Ascentis® Phenyl
(length 250 mm, internal diameter 4.6 mm, particle size 5μm) as a stationary
phase, mixed mobile phase of acetonitrile and buffer phosphate KH2PO4 20 mM
and SDS 1 mM pH 4.0 ± 0,1 adjusted with dilute ortho phosphoric acid 10 % (30 :
70 v/v), the flow rate 1.0 mL/minute, detected by UV detector 234 nm. The
method was validated with the parameters selectivity, LOD, LOQ, linearity,
precision, accuracy and robustness.
The validation result shows that this method has selectivity, accuracy,
repeatability and intermediate precision also good robustness for the
determination of metformin HCl in spiked plasma and tablet dosage form. Range
of linearity is on 0.1 - 7 mg/mL. LOD 29.0 ng/mL and LOQ 90.7 ng/mL.
Conclusion, the analytical method that was developed can be used to
determination metformin HCl in spiked human plasma and in tablet dosage form |
| first_indexed | 2024-03-13T23:38:32Z |
| format | Thesis |
| id | oai:generic.eprints.org:133192 |
| institution | Universiti Gadjah Mada |
| last_indexed | 2024-03-13T23:38:32Z |
| publishDate | 2014 |
| publisher | [Yogyakarta] : Universitas Gadjah Mada |
| record_format | dspace |
| spelling | oai:generic.eprints.org:1331922016-03-04T08:12:44Z https://repository.ugm.ac.id/133192/ PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET , SISKA RUSMALINA , Dr, RR. Endang Lukitaningsih, M.Si., Apt ETD Metformin is a polar compound if analyzed by reversed-phase of HPLC will appear in a fast retention time, this complicates the determination of metformin in plasma due to be overlapping between metformin peak compound with endogenous peak compounds in plasma. To solve it, ion pairing reagent sodium dodesil sulfate (SDS) is used. The purpose of this study is to develop and validate the analytical methods metformin assay in spiked human plasma and tablet dosage form by HPLC using a reversed-phase column Supelco Ascentis® Phenyl (length 250 mm, internal diameter 4.6 mm, particle size 5μm). HPLC system consisted of a reversed-phase column Ascentis® Phenyl (length 250 mm, internal diameter 4.6 mm, particle size 5μm) as a stationary phase, mixed mobile phase of acetonitrile and buffer phosphate KH2PO4 20 mM and SDS 1 mM pH 4.0 ± 0,1 adjusted with dilute ortho phosphoric acid 10 % (30 : 70 v/v), the flow rate 1.0 mL/minute, detected by UV detector 234 nm. The method was validated with the parameters selectivity, LOD, LOQ, linearity, precision, accuracy and robustness. The validation result shows that this method has selectivity, accuracy, repeatability and intermediate precision also good robustness for the determination of metformin HCl in spiked plasma and tablet dosage form. Range of linearity is on 0.1 - 7 mg/mL. LOD 29.0 ng/mL and LOQ 90.7 ng/mL. Conclusion, the analytical method that was developed can be used to determination metformin HCl in spiked human plasma and in tablet dosage form [Yogyakarta] : Universitas Gadjah Mada 2014 Thesis NonPeerReviewed , SISKA RUSMALINA and , Dr, RR. Endang Lukitaningsih, M.Si., Apt (2014) PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET. UNSPECIFIED thesis, UNSPECIFIED. http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=73752 |
| spellingShingle | ETD , SISKA RUSMALINA , Dr, RR. Endang Lukitaningsih, M.Si., Apt PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title | PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT
DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title_full | PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT
DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title_fullStr | PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT
DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title_full_unstemmed | PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT
DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title_short | PENGEMBANGAN DAN VALIDASI METODE PENETAPAN METFORMIN HIDROKLORIDA SECARA KCKT
DALAM SPIKED PLASMA MANUSIA DAN PADA SEDIAAN TABLET |
| title_sort | pengembangan dan validasi metode penetapan metformin hidroklorida secara kckt dalam spiked plasma manusia dan pada sediaan tablet |
| topic | ETD |
| work_keys_str_mv | AT siskarusmalina pengembangandanvalidasimetodepenetapanmetforminhidrokloridasecarakcktdalamspikedplasmamanusiadanpadasediaantablet AT drrrendanglukitaningsihmsiapt pengembangandanvalidasimetodepenetapanmetforminhidrokloridasecarakcktdalamspikedplasmamanusiadanpadasediaantablet |