Method development, validation, identification and quantification of residual solvents in phenazopyridine hydrochloride using head space–gas chromatography technique

2021 ◽  
Author(s):  
Narmada Vallakeerthi ◽  
Anisetti Ravinder Nath
Keyword(s):  
Gas Chromatography ◽  
Method Development ◽  
Residual Solvents ◽  
Head Space ◽  
Head Space Gas Chromatography ◽  
Identification And Quantification

scholarly journals Residual solvent determination by head space gas chromatography with flame ionization detector in omeprazole API

2011 ◽  
Vol 47 (2) ◽  
pp. 379-384 ◽  
Author(s):  
Saurabh Pandey ◽  
Preeti Pandey ◽  
Raj Kumar ◽  
Narendra Pal Singh
Keyword(s):  
Gas Chromatography ◽  
Active Pharmaceutical Ingredient ◽  
Reversible Inhibitor ◽  
Internal Diameter ◽  
Residual Solvent ◽  
Residual Solvents ◽  
Pharmaceutical Ingredients ◽  
Flame Ionization ◽  
Head Space ◽  
Head Space Gas Chromatography

Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space. Based on good manufacturing practices, measuring residual solvents is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents (methanol, acetone, cyclohexane, dichloromethane, toluene) in Omeprazole, an active pharmaceutical ingredient was investigated. Omeprazole is a potent reversible inhibitor of the gastric proton pump H+/K+-ATPase. The Head space gas chromatography (HSGC) method described in this investigation utilized a SPB TM-624, Supelco, 30 m long x 0.25 mm internal diameter, 1.4µm-thick column. Since Omeprazole is a thermally labile compound, the selection of the proper injector temperature is critical to the success of the analysis. The injector temperature was set at 170ºC to prevent degradation. The initial oven temperature was set at 40ºC for 12 min and programmed at a rate of 10ºC min-1 to a final temperature of 220ºC for 5 min. Nitrogen was used as a carrier gas. The sample solvent selected was N,N-dimethylacetamide. The method was validated to be specific, linear, precise, sensitive, rugged and showed excellent recovery.

scholarly journals Analysis of Residual Solvents in Flavor Preparations by Head-Space Gas Chromatography

1997 ◽  
Vol 38 (2) ◽  
pp. 97-104_1 ◽  
Author(s):  
Yoko UEMATSU ◽  
Yuki SADAMASU ◽  
Keiko HIRATA ◽  
Masako HIROKADO ◽  
Kazuo YASUDA ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Residual Solvents ◽  
Head Space ◽  
Head Space Gas Chromatography

Effect Of Water On Head Space-Gas Chromatography Odorants Signals From Orange Juice: A Possible Influence On Odor Intensity

LWT ◽  
2021 ◽  
pp. 111712
Author(s):  
David Reznik ◽  
Aviv Kaplan ◽  
Igal Gozlan ◽  
Gefen Ronen-Eliraz ◽  
Dror Avisar
Keyword(s):  
Gas Chromatography ◽  
Orange Juice ◽  
Odor Intensity ◽  
Effect Of Water ◽  
Head Space ◽  
Head Space Gas Chromatography

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

2021 ◽  
pp. 2440-2444
Author(s):  
Sanapala Srinivasa Rao ◽  
A. Vijayalakshmi
Keyword(s):  
Gas Chromatography ◽  
Method Development ◽  
Limit Of Detection ◽  
Dimethyl Formamide ◽  
Analytical Methodology ◽  
Residual Solvents ◽  
Flame Ionization ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

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.

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