Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography

Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography Sanapala Srinivasa Rao School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai-117, Tamil Nadu, India. A. Vijayalakshmi School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai-117, Tamil Nadu, India.
Residual solvents in Pharmaceuticals are termed as organic volatile impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical methodology was developed for the quantification of residual solvents in Glipizide using a headspace gas chromatography (HSGC) with the help of flame ionization detector (FID). Methanol, acetone and dimethyl formamide as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Auto system- HS40. Nitrogen was used as a carrier gas and the separation of residual solvents was achieved by DB-Wax 0.25mm, 0.3mcm column. The thermostat temperature was 115 °C for 40 minutes for each vial. % RSD for nine injections obtained are in acceptance criteria. The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated includes specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. According to the International Conference on Harmonization (ICH) guidelines, a new simple, specific, accurate and precise method was developed and validated.
5 26 2021 5 26 2021 2440 2444 10.52711/0974-360X.2021.00429 https://rjptonline.org/AbstractView.aspx?PID=2021-14-5-13 Grodowska K. et.al, A. Analytical methods for residual solvents determination in pharmaceutical products. Acta Poloniae Pharmaceutica and Drug Research, 2010, 67(1), 1326. Reddy, P. B. et.al, Residual Solvents Determination by HS-GC with Flame Ionization Detector in Omeprazole Pharmaceutical formulations. International Journal of Pharm. Tech. Research, 2009 ,1 (2), 230-234. 10.1016/S0378-4347(00)81264-5 Hartvig P. et.al, Electron-capture gas chromatography of plasma sulfonylureas after extractive methylation, J .Chromatography, 1980, 181(1),17-24. 10.1016/j.jchromb.2004.12.018 Abu Ruz, S. et.al, The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. Journal of Chromatography B, 2005, 817(2), 277-286. AHFS Drug Information, American Society of Health-System Pharmacists, Bethesda, MD, 2001. 10.1002/bmc.723 Ding, C.-G, et.al, Simultaneous determination of metformin and glipizide in human plasma by liquid chromatography–tandem mass spectrometry. Biomedical Chromatography, 2007, 21(2), 132-138.