Modification of a previously published HPLC-UV method for metformin determination, validation and application to test bioequivalence

Abstract EN

The aims were to overcome the problem of peak deterioration caused by HCl used in a sample preparation and validate and apply the modified method to test the bioequivalence of Glystor (Algorithm S.A.L., Lebanon) and Glucophage® (Merck Santé S.A.S., France) tablets.

Non-acidified samples were prepared by protein precipitation followed by washing with dichloromethane.

The mobile phase consisted of acetonitrile and phosphate buffer (65 : 35) pH 7.5.

A Hypersil silica column was used.

The method was validated according to the FDA guidance and applied to test bioequivalence.

No deterioration in the peak shape was observed.

Only two columns were used during validation and analysis.

Good separation of atenolol and metformin was achieved.

Calibration curves (40-2000 ng / ml) were linear.

Accuracy and precisions were within required limits.

Absolute recoveries were > 78.30 %.

Metformin was stable in stock solution and in plasma during processing and storage.

Statistical analysis of pharmacokinetic parameters demonstrated bioequivalence.

In conclusion, the modified method was functional and the two products were bioequivalent.