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

Yahdiana Harahap,Citra Dara Malia ,Sunarsih Sunarsih

doi:10.22159/ijap.2018.v10s1.78

Yahdiana Harahap, Citra Dara Malia + Show 1 more

Open Access

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

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Abstract

Objective: This study aimed to analyze the metformin hydrochloride in dried blood spot (DBS) sample and evaluate a pharmacokinetic profile in sixhealthy 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. Bloodsamples 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 obtainedusing 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.

Highlights

Diabetes mellitus (DM) is a disorder of carbohydrate, protein, and fat metabolism due to decreased insulin secretion, insulin receptor sensitivity, or both and can be identified by hyperglycemia in the patient [1]
The aim of the present study was to the analyze 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 (HPLC)–Photodiode array (PDA)
Metformin hydrochloride analysis in the sample Analysis was performed using HPLC–PDA (100-μL sample injection volume) with an optimized mobile phase to determine the concentration of metformin hydrochloride in healthy subjects who administered 850mg metformin hydrochloride in tablet to evaluate the pharmacokinetic profile

Summary

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

INTRODUCTION

METHODS

RESULTS AND DISCUSSION