PHARMACOKINETIC PROFILE OF METFORMIN HYDROCHLORIDE IN DRIED BLOOD SPOT OF HEALTHY SUBJECTS USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–PHOTODIODE ARRAY

Authors

  • Yahdiana Harahap Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok 16424, Indonesia.
  • Citra Dara Malia Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok 16424, Indonesia.
  • Sunarsih . Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok 16424, Indonesia.

DOI:

https://doi.org/10.22159/ijap.2018.v10s1.78

Keywords:

Dried blood spot, High-performance liquid chromatography, Metformin hydrochloride, Pharmacokinetic profile, Validation

Abstract

Objective: This study aimed to analyze the metformin hydrochloride in dried blood spot (DBS) sample and evaluate a pharmacokinetic profile in six
healthy subjects who administered 850-mg metformin hydrochloride in tablet using high-performance liquid chromatography–photodiode array
(HPLC–PDA).
Methods: Metformin analysis was performed on data of six healthy subjects who administered 850 mg of metformin hydrochloride as tablets. Blood
samples were taken at 12-time points at intervals of up to 12 h, and data were analyzed using HPLC–PDA.
Results: A linear calibration curve was obtained in the range of 25–5000 ng/mL, with r=0.9990. Pharmacokinetic profiles of metformin were obtained
using DBS samples from six healthy participants, with a Cmax of 347.3–416.22 ng/mL. The average tmax and t1/2 were obtained at 3 and 2 h, respectively,
and the area under the curve (AUC)0-t/AUC0-∞ ratio was >80% for all subjects.
Conclusion: The DBS biosampling technique can be developed for application in pharmacokinetic study of metformin HCl.

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References

Dipiro J, Dipiro CV, Wells BG, Scwinghammer TL. Pharmacotherapy

a Pathophysiologic Approach. 9th ed. United States: The McGraw-Hill

Companies, Inc.; 2015.

Muchid A. Pharmaceutical Care for Diabetes Mellitus. Jakarta:

Indonesian Ministry of Health; 2005.

Aburuz S, Millership J, McElnay J. Dried blood spot liquid

chromatography assay for therapeutic drug monitoring of metformin.

J Chromatogr B Analyt Technol Biomed Life Sci 2006;832:202-7.

Indonesian National Agency of Food and Drug Control. Regulation

from Head of No. HK.03.1.23.12.11.10217 about Drug Obligate

Equivalence Study Jakarta. Jakarta: Indonesian National Agency of

Food and Drug Control; 2011.

Tan MH, Alquraini H, Mizokami-Stout K, MacEachern M. Metformin:

From research to clinical practice. Endocrinol Metab Clin North Am

;45:819-43.

Earle RR, Bandaru KK, Lakshmi UA. Formulation and characterization

of sustained release coated matric granules of metformin hydrochloride.

Asian J Pharm Clin Res 2018;11:387-92.

Kotecha NC, Patel JK. Method development and validation of a

reversed-phase liquid chromatographic method for the simultaneous

estimation of selected anti diabetic drugs in the presence of their

degradation products. Asian J Pharm Clin Res 2018;11:345-52.

Bookya P, Raparla R, Sriamula HP, Tarrigopula S, Vanga S. Formulation

and evaluation of metformin hydrochloride sustained release oral

matrix tablets. Asian J Pharm Clin Res 2018;11:342-5.

Evans C, Arnold M, Bryan P, Duggan J, James CA, Li W, et al.

Implementing dried blood spot sampling for clinical pharmacokinetic

determinations: Considerations from the IQ consortium microsampling

working group. AAPS J 2015;17:292-300.

Center of Drug Evaluation and Research. Metformin Hydrochloride

Tablets. United States: Food and Drug Administration; 2002.

Scherf-Clavel M, Högger P. Analysis of metformin, sitagliptin and

creatinine in human dried blood spots. J Chromatogr B Analyt Technol

Biomed Life Sci 2015;997:218-28.

Wilhelm AJ, den Burger JC, Swart EL. Therapeutic drug monitoring

by dried blood spot: Progress to date and future directions. Clin

Pharmacokinet 2014;53:961-73.

Alshishani A, Makahleh A, Yap HF, Gubartallah EA, Salhimi SM, Saad B,

et al. Ion-pair vortex assisted liquid-liquid microextraction with back

extraction coupled with high performance liquid chromatography-UV for

the determination of metformin in plasma. Talanta 2016;161:398-404.

Evans G. A Handbook of Bioanalysis and Drug Metabolism. United

States of America: CRC Press; 2014.

Porta V, Schramm S, Kano E, Koono E, Armando Y, Fukuda K, et al.

HPLC-UV determination of metformin in human plasma for application

in pharmacokinetics and bioequivalence studies. J Pharm Biomed Anal

;46:143-7.

Sharma A, Jaiswal S, Shukla M, Lal J. Dried blood spots: Concepts,

present status, and future perspectives in bioanalysis. Drug Test Anal

;6:399-414.

Published

20-12-2018

How to Cite

Harahap, Y., Malia, C. D., & ., S. (2018). PHARMACOKINETIC PROFILE OF METFORMIN HYDROCHLORIDE IN DRIED BLOOD SPOT OF HEALTHY SUBJECTS USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–PHOTODIODE ARRAY. International Journal of Applied Pharmaceutics, 10(1), 354–357. https://doi.org/10.22159/ijap.2018.v10s1.78

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