Validation of an HPLC-UV Method for the determination of metformin hydrochloride in spiked-Human plasma for the application of therapeutic drug monitoring

Ningrum, Vitarani Dwi Ananda; Wibowo, Ari; Fuaida, Isma; Ikawati, Zullies; Sadewa, Ahmad Hamim; Ikhsan, Mohammad Robikhul

doi:10.5958/0974-360x.2018.00406.7

Cited by 9 publications

(9 citation statements)

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“…The significant modification from the previous study [12][13][14][15][18][19]26] concerns the extraction method, composition, and preparation procedure of the mobile phase, as well as the concentration range of the calibration curve and quality control samples, taking into account the therapeutic range of metformin in the plasma of the patients with diabetes mellitus. Optimization of several alternative extraction methods was carried out in the preliminary study, including protein precipitation with trichloroacetic acid and acetonitrile.…”

Section: Methods Developmentmentioning

confidence: 99%

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Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study

Adhi Pradana,

Kristin,

Nugroho

et al. 2023

Indones. J. Chem.

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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.

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Section: Methods Developmentmentioning

confidence: 99%

“…Therefore, protein precipitation has been the preferred sample preparation approach to address metformin extraction's difficulty. However, this method's time retention is too short, has poor recovery [19] and is ineffective in removing endogenous interferences [18][19].…”

Section: ■ Introductionmentioning

confidence: 99%

Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study

Adhi Pradana,

Kristin,

Nugroho

et al. 2023

Indones. J. Chem.

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“…The samples were then delivered to the Laboratory of Drugs, Food, and Cosmetics of the Pharmacy Department of Universitas Islam Indonesia to PLOS ONE be centrifuged for 10 minutes at 3500g, and the plasma aliquot was stored in a 2-ml polypropylene tube at -20˚C in a maximum of one hour after the sampling. The metformin plasma concentrations were determined through a validated reversed-phase high performance liquid chromatography (HPLC) assay with Sunfire1 C-18 column, 4.6 x 150mm x 5μm from Waters, and SM7 injector with an ultraviolet (UV) detector at 234 nm wavelength [19]. The metformin PSSC could estimate the elimination rate, and the metformin half-life was also calculated using the following formula [20].…”

Section: Pharmacokinetics Of Metformin Steady-state Concentrationsmentioning

confidence: 99%

The influence of metformin transporter gene SLC22A1 and SLC47A1 variants on steady-state pharmacokinetics and glycemic response

et al. 2022

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Interindividual variation is important in the response to metformin as the first-line therapy for type-2 diabetes mellitus (T2DM). Considering that OCT1 and MATE1 transporters determine the metformin pharmacokinetics, this study aimed to investigate the influence of SLC22A1 and SLC47A1 variants on the steady-state pharmacokinetics of metformin and the glycemic response. This research used the prospective-cohort study design for 81 patients with T2DM who received 500 mg metformin twice a day from six primary healthcare centers. SLC22A1 rs628031 A>G (Met408Val) and Met420del genetic variants in OCT1 as well as SLC47A1 rs2289669 G>A genetic variant in MATE1 were examined through the PCR-RFLP method. The bioanalysis of plasma metformin was performed in the validated reversed-phase HPLC-UV detector. The metformin steady-state concentration was measured for the trough concentration (Cssmin) and peak concentration (Cssmax). The pharmacodynamic parameters of metformin use were the fasting blood glucose (FBG) and glycated albumin (GA). Only SLC22A1 Met420del alongside estimated-glomerular filtration rate (eGFR) affected both Cssmax and Cssmin with an extremely weak correlation. Meanwhile, SLC47A1 rs2289669 and FBG were correlated. This study also found that there was no correlation between the three SNPs studied and GA, so only eGFR and Cssmax influenced GA. The average Cssmax in patients with the G allele of SLC22A1 Met408Val, reaching 1.35-fold higher than those with the A allele, requires further studies with regard to metformin safe dose in order to avoid exceeding the recommended therapeutic range.

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“…Following a thorough study of the literature, several methods for analyzing MET alone in various samples (plasma, urine, liver, brain, kidney, and muscles) were reported, including HPLC [14][15][16][17][18][19], HILIC [20], LC/MS/MS [21][22][23][24], HILIC/MS [25], and GC/MS [26]. MET in conjunction with various medications in various plasma samples was also estimated by HPLC [27][28][29][30][31][32], LC/MS/MS [33][34][35][36][37][38][39][40], and HILIC/MS [41,42] methods.…”

Section: Introductionmentioning

confidence: 99%

Development and Greenness Assessment of HPLC Method for Studying the Pharmacokinetics of Co-Administered Metformin and Papaya Extract

et al. 2022

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Foods with medical value have been proven to be beneficial, and they are extensively employed since they integrate two essential elements: food and medication. Accordingly, diabetic patients can benefit from papaya because the fruit is low in sugar and high in antioxidants. An RP-HPLC method was designed for studying the pharmacokinetics of metformin (MET) when concurrently administered with papaya extract. A mobile phase of 0.5 mM of KH2PO4 solution and methanol (65:35, v/v), pH = 5 ± 0.2 using aqueous phosphoric acid and NaOH, and guaifenesin (GUF) were used as an internal standard. To perform non-compartmental pharmacokinetic analysis, the Pharmacokinetic program (PK Solver) was used. The method’s greenness was analyzed using two tools: the Analytical GREEnness calculator and the RGB additive color model. Taking papaya with MET improved the rate of absorption substantially (time for reaching maximum concentration (Tmax) significantly decreased by 75% while maximum plasma concentration (Cmax) increased by 7.33%). The extent of absorption reduced by 22.90%. Furthermore, the amount of medication distributed increased (30.83 L for MET concurrently used with papaya extract versus 24.25 L for MET used alone) and the clearance rate rose by roughly 13.50%. The results of the greenness assessment indicated that the method is environmentally friendly. Taking papaya with MET changed the pharmacokinetics of the drug dramatically. Hence, this combination will be particularly effective in maintaining quick blood glucose control.

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Validation of an HPLC-UV Method for the determination of metformin hydrochloride in spiked-Human plasma for the application of therapeutic drug monitoring

Cited by 9 publications

References 0 publications

Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study

Bioanalytical Method Validation of Metformin Hydrochloride in Human Plasma by HPLC-UV for Preliminary Population-Based Pharmacokinetic Modeling Study

The influence of metformin transporter gene SLC22A1 and SLC47A1 variants on steady-state pharmacokinetics and glycemic response

Development and Greenness Assessment of HPLC Method for Studying the Pharmacokinetics of Co-Administered Metformin and Papaya Extract

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