Fast HPLC method for the determination of glimepiride, glibenclamide, and related substances using monolithic column and flow program.
This work presents a fast method for the simultaneous separation and determination of glimepiride, glibenclamide, and two related substances by RP LC. The separation was performed on a Chromolith Performance (RP-18e, 100 mm x 4.6 mm) column. As mobile phase, a mixture of phosphate buffer pH 3, 7.4 mM, and ACN (55:45 v/v) was used. Column oven temperature was set to 30 degrees C. The total chromatographic run time was 80 s. This was achieved using a flow program from 5 to 9.9 mL/min. Precisions of the interday and the intraday assay for both retention times and peak areas for the four analyzed compounds were less than 1.2%. The method showed good linearity and recovery. The short analysis time makes the method very valuable for quality control and stability testing of drugs and their pharmaceutical preparations.
El Deeb
Sami
S
Institute of Pharmaceutical Chemistry, TU Braunschweig, Braunschweig, Germany.
Schepers
Udo
U
Wätzig
Hermann
H
D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D005905:Glyburide / Q000031:analogs & derivatives / Q000032:analysis* / Q000592:standards; D007004:Hypoglycemic Agents / Q000032:analysis / Q000592:standards; D012015:Reference Standards; D013453:Sulfonylurea Compounds / Q000032:analysis* / Q000592:standards
D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride; D005905:Glyburide