LC determination of glimepiride and its related impurities.
Five impurities in glimepiride drug substance were detected and quantified using a simple isocratic reverse phase HPLC method. For the identification and characterization purpose these impurities were isolated from a crude reaction mixture of glimepiride using a normal phase HPLC system. Based on the spectroscopic data like NMR, FTIR, UV and MS these impurities were characterized and used as impurity standards for determining the relative response factor during the validation of the proposed isocratic reverse phase HPLC method. The chromatographic separation was achieved on a Phenomenex Luna C8 (2) 100 A, 5 microm, 250 mm x 4.6 mm using a mobile phase consisting of phosphate buffer (pH 7.0)-acetonitrile-tetrahydrofuran (73:18:09, v/v/v) with UV detection at 228 nm and a flow rate of 1 ml/min. The column temperature was maintained at 35 degrees C through out the analysis. The method has been validated as per international guidelines on method validation and can be used for the routine quality control analysis of glimepiride as active pharmaceutical ingredient (API).
Khan
Mubeen Ahmad
MA
Analytical Research Lab, Glenmark Research Centre, Plot A-607, TTC Industrial Area, MIDC, Mahape, 400709 Navi Mumbai, India. mubeen_khan@glenmarkpharma.com
Sinha
Sukumar
S
Vartak
Santosh
S
Bhartiya
Atul
A
Kumar
Shankar
S
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D007004:Hypoglycemic Agents / Q000032:analysis*; D007202:Indicators and Reagents; D007536:Isomerism; D009682:Magnetic Resonance Spectroscopy; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D021241:Spectrometry, Mass, Electrospray Ionization; D013056:Spectrophotometry, Ultraviolet; D017550:Spectroscopy, Fourier Transform Infrared; D013453:Sulfonylurea Compounds / Q000032:analysis*
D007004:Hypoglycemic Agents; D007202:Indicators and Reagents; D012996:Solutions; D013453:Sulfonylurea Compounds; C057619:glimepiride