Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study
This study aims to validate the method for measuring metformin hydrochloride plasma concentrations using High-Performance Liquid Chromatography (HPLC). This research performed chromatography on a 250 mm 4.6 mm 5 µm purosphere® Star RP-18 column at ambient temperature with a UV detector system at 233...
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| Format: | Article |
| Language: | English |
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Department of Chemistry, Universitas Gadjah Mada
2023-08-01
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| Series: | Indonesian Journal of Chemistry |
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| Online Access: | https://jurnal.ugm.ac.id/ijc/article/view/77903 |
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| author | Dimas Adhi Pradana Erna Kristin Akhmad Kharis Nugroho Dwi Aris Agung Nugrahaningsih Mustofa Mustofa Ari Wibowo |
| author_facet | Dimas Adhi Pradana Erna Kristin Akhmad Kharis Nugroho Dwi Aris Agung Nugrahaningsih Mustofa Mustofa Ari Wibowo |
| author_sort | Dimas Adhi Pradana |
| collection | DOAJ |
| description | This study aims to validate the method for measuring metformin hydrochloride plasma concentrations using High-Performance Liquid Chromatography (HPLC). This research performed chromatography on a 250 mm 4.6 mm 5 µm purosphere® Star RP-18 column at ambient temperature with a UV detector system at 233 nm. The mobile phase components were 70% phosphate buffer (KH2PO4) (10 mM), sodium dodecyl sulfate (0.3 mM), and 30% acetonitrile. It was pumped at an isocratic flow rate of 1.2 mL/min. Metformin HCl and ranitidine HCl (internal standard) were extracted using acetonitrile. The calibration curve was linear (R2 = 0.9998) in the 0.18–6 µg/mL concentration range. The lower limit of quantification (LLOQ) was 0.18 µg/mL. For intraday accuracy and precision, the percent difference and the coefficient of variation were less than 4 and 7%, and for inter-day were lower than 8 and 6%. The recovery average was 100.96%. The short-term plasma stability test was stable at 24 h at ambient temperature, and the long-term stability test was steady for 30 d at −20 °C. It was also stable after three freeze-thaw cycles. The method meets selectivity, sensitivity, linearity, accuracy, precision, recovery, carryover, and stability requirements and can be applied to population-based pharmacokinetic modeling. |
| first_indexed | 2024-03-12T14:44:31Z |
| format | Article |
| id | doaj.art-f9d8b6fec6e5498ca4ac5cea42fc4dbe |
| institution | Directory Open Access Journal |
| issn | 1411-9420 2460-1578 |
| language | English |
| last_indexed | 2024-03-12T14:44:31Z |
| publishDate | 2023-08-01 |
| publisher | Department of Chemistry, Universitas Gadjah Mada |
| record_format | Article |
| series | Indonesian Journal of Chemistry |
| spelling | doaj.art-f9d8b6fec6e5498ca4ac5cea42fc4dbe2023-08-16T03:28:31ZengDepartment of Chemistry, Universitas Gadjah MadaIndonesian Journal of Chemistry1411-94202460-15782023-08-0123493794710.22146/ijc.7790334100Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling StudyDimas Adhi Pradana0Erna Kristin1Akhmad Kharis Nugroho2Dwi Aris Agung Nugrahaningsih3Mustofa Mustofa4Ari Wibowo5Department of Pharmacy, Universitas Islam Indonesia, Jl. Kaliurang km. 14, Yogyakarta 55584, Indonesia; Department of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Jl. Farmako, Sekip Utara, Yogyakarta 55281, IndonesiaDepartment of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Jl. Farmako, Sekip Utara, Yogyakarta 55281, IndonesiaFaculty of Pharmacy, Universitas Gadjah Mada, Sekip Utara, Yogyakarta 55281, IndonesiaDepartment of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Jl. Farmako, Sekip Utara, Yogyakarta 55281, IndonesiaDepartment of Pharmacology and Therapy, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Jl. Farmako, Sekip Utara, Yogyakarta 55281, IndonesiaDepartment of Pharmacy, Universitas Islam Indonesia, Jl. Kaliurang km. 14, Yogyakarta 55584, IndonesiaThis study aims to validate the method for measuring metformin hydrochloride plasma concentrations using High-Performance Liquid Chromatography (HPLC). This research performed chromatography on a 250 mm 4.6 mm 5 µm purosphere® Star RP-18 column at ambient temperature with a UV detector system at 233 nm. The mobile phase components were 70% phosphate buffer (KH2PO4) (10 mM), sodium dodecyl sulfate (0.3 mM), and 30% acetonitrile. It was pumped at an isocratic flow rate of 1.2 mL/min. Metformin HCl and ranitidine HCl (internal standard) were extracted using acetonitrile. The calibration curve was linear (R2 = 0.9998) in the 0.18–6 µg/mL concentration range. The lower limit of quantification (LLOQ) was 0.18 µg/mL. For intraday accuracy and precision, the percent difference and the coefficient of variation were less than 4 and 7%, and for inter-day were lower than 8 and 6%. The recovery average was 100.96%. The short-term plasma stability test was stable at 24 h at ambient temperature, and the long-term stability test was steady for 30 d at −20 °C. It was also stable after three freeze-thaw cycles. The method meets selectivity, sensitivity, linearity, accuracy, precision, recovery, carryover, and stability requirements and can be applied to population-based pharmacokinetic modeling.https://jurnal.ugm.ac.id/ijc/article/view/77903human plasmahplc-uvmetformin hclpharmacokineticvalidation |
| spellingShingle | Dimas Adhi Pradana Erna Kristin Akhmad Kharis Nugroho Dwi Aris Agung Nugrahaningsih Mustofa Mustofa Ari Wibowo Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study Indonesian Journal of Chemistry human plasma hplc-uv metformin hcl pharmacokinetic validation |
| title | Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study |
| title_full | Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study |
| title_fullStr | Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study |
| title_full_unstemmed | Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study |
| title_short | Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study |
| title_sort | bioanalytical method validation of metformin hydrochloride in human plasma by hplc uv for preliminary population based pharmacokinetic modeling study |
| topic | human plasma hplc-uv metformin hcl pharmacokinetic validation |
| url | https://jurnal.ugm.ac.id/ijc/article/view/77903 |
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