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Published on: December 15, 2015
Fast HPLC method for the determination of glimepiride, glibenclamide, and related substances using monolithic column
Sami El Deeb1, Udo Schepers, Hermann Wätzig
1Institute of Pharmaceutical Chemistry, TU Braunschweig, Braunschweig, Germany.
Abstract:
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.
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