Development and validation of HPLC-UV method for determination of Metformin Hydrochloride in Tablets available in the Libyan market

Osama I. G. Khreit; Marwa M. Bader; Amna M. Imbarak; Khoud M. Yacoub; Khawla A. Jomaa; Rowaida A. Aboubakr

doi:10.54172/mjsc.1349

Authors

Osama I. G. Khreit Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, Omar Al Mukhtar University, Libya
Marwa M. Bader Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Omar Al Mukhtar University, Libya
Amna M. Imbarak Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Omar Al Mukhtar University, Libya
Khoud M. Yacoub Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Omar Al Mukhtar University, Libya
Khawla A. Jomaa Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Omar Al Mukhtar University, Libya
Rowaida A. Aboubakr Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, Omar Al Mukhtar University, Libya

DOI:

https://doi.org/10.54172/mjsc.1349

Keywords:

HPLC, Metformin HCl, Tablets, Validation

Abstract

A rapid and simple HPLC-UV method has been developed and validated for the estimation of metformin HCl formulated in tablet dosage form, as well as to identify different commercial brands of metformin HCl using BP test Thin Layer Chromatography. The HPLC method was performed on a Reversed-Phase Brownlee Bio C18 column (250 x 4.6 mm, 5 μm) at a 1.0 mL min^-1 flow rate with UV detection at 236 nm. The mobile phase was conducted in an isocratic manner and contained 52% acetonitrile and 48% aqueous phase (0.1M Potassium dihydrogen orthophosphate). The pH of the aqueous phase was adjusted to 5.5. The validation of the analytical method for determination of metformin HCl in tablet formulation was performed following parameters including system suitability, specificity, the limit of quantification, limit of detection, peak shapes, and asymmetries have resulted. The precision was calculated and showed excellent reproducibility (RSD = 0. 1-0.57 %, n=3). The linearity of the method has been tested in the range of 4.0–12.0 µg mL^-1 for metformin HCl. The limits of detection and quantification have been also established to be lower than 2.7 µg mL^-1 and 8.0 µg mL^-1, respectively. This method is suitable to estimate pharmaceutical formulations with no interference from excipients.

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