alexa Abstract | Analytical Method Development to Determine Residual Solvents in Glipizide by Gas Chromatography (GC/FID) with Head Space


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Abstract

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. Analysis of organic volatile impurities is of key importance for Active Pharmaceutical Ingredients (API). Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical method for the quantification of residual solvents in Glipizide was established using a headspace gas chromatography (HSGC) coupled with a flame ionization detector (FID). Methanol, acetone and ethylene dichloride as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Agilent GC 7820A system. Nitrogen was used as a carrier gas with constant flow rate of 4.2 mL/min and the separation of residual solvents was achieved on DB-624 column. The thermostat temperature was 100 °C for 30 minute for each vial and after the equilibration the vials were pressurized and injected on GC column. The %RSD for six injections obtained in acceptance criteria. The percentage recovery ranges obtained from 92.49 and 106.69%.The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated included specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. A new, simple, specific, accurate and precise method was validated according to the International Conference on Harmonization (ICH) guidelines.

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Author(s): Ojas Joshi, Parag Gide, Nitin Nimkar

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