scholarly journals Development and validation of a headspace gas chromatographic method for the determination of residual solvents in arterolane (RBx11160) maleate bulk drug

2010 ◽  
Vol 2 (1) ◽  
pp. 32 ◽  
Author(s):  
Abhishek Gupta ◽  
Yogendra Singh ◽  
KonaS Srinivas ◽  
Garima Jain ◽  
VB Sreekumar ◽  
...  
Keyword(s):  
Chromatographic Method ◽  
Residual Solvents ◽  
Headspace Gas ◽  
Bulk Drug ◽  
Gas Chromatographic Method ◽  
Development And Validation

Development and Validation of a Headspace Gas Chromatographic Method for the Determination of Methyl Bromide Content in Itraconazole API

2015 ◽  
Vol 59 ◽  
pp. 160-169
Author(s):  
Mannem Durga Babu ◽  
Medikondu Kishore ◽  
K. Surendra Babu
Keyword(s):  
Methyl Bromide ◽  
Chromatographic Method ◽  
Limit Of Detection ◽  
Limit Of Quantitation ◽  
Headspace Gas ◽  
Current Article ◽  
Bulk Drug ◽  
Gas Chromatographic Method ◽  
Development And Validation

To provide quality control over the manufacture of any API, it is essential to develop highly selective analytical methods. Gas chromatography with headspace (HSGC) is widely used for the determination of residual impurities and solvents in API’s. In the current article we are reporting the development and validation of a rapid and specific Head space gas chromatographic (HSGC) method for the determination of methyl bromide in Itraconazole API. The developed method was validated in terms of specificity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ). The developed method was utilized for the investigation of methyl bromide content in bulk drug.

Determination of Residual Ethylene Oxide in Spectinomycin Hydrochloride Bulk Drug by Dynamic Headspace Gas Chromatography

1993 ◽  
Vol 76 (2) ◽  
pp. 313-319
Author(s):  
Tore Ramstad ◽  
Lisa S Miller ◽  
Virginia N Thomas
Keyword(s):  
Detection Limit ◽  
Ethylene Oxide ◽  
Chromatographic Method ◽  
Headspace Gas Chromatography ◽  
Dynamic Headspace ◽  
Relative Standard ◽  
Headspace Gas ◽  
Bulk Drug ◽  
Gas Chromatographic Method

Abstract A dynamic headspace gas chromatographic method was developed for the determination of residual ethylene oxide (EtO) in a pharmaceutical bulk drug, spectinomycin hydrochloride. The recommended column is PoraPLOT Q; PoraPLOT U was demonstrated to be equivalent. A detection limit of 2 ppb was achieved, and linearity was established to the highest value tested (5 ppm). The detection limit was 2-3 orders of magnitude lower than that achieved in previously published methods for EtO in pharmaceutical bulk drugs. Precision studies yielded relative standard deviations ranging from 2 to 10% over the 10-575 ppb concentration range. The method was applied to support EtO sterilization studies conducted at The Upjohn Company and was implemented for routine use. The sterilization studies demonstrated that residual levels of EtO <10 ppb are achievable.

Static headspace gas chromatographic method for the determination of residual solvents in cephalosporins

RSC Advances ◽  
2015 ◽  
Vol 5 (22) ◽  
pp. 17150-17159 ◽  
Author(s):  
Mohamed Gad ◽  
Hala Zaazaa ◽  
Sawsan Amer ◽  
Mohamed Korany
Keyword(s):  
Pharmaceutical Industry ◽  
Chromatographic Method ◽  
Static Headspace ◽  
Residual Solvents ◽  
Headspace Gas ◽  
Gas Chromatographic Method ◽  
Daunting Challenge

The pharmaceutical industry is facing a daunting challenge in the control of impurities.

A Headspace Gas Chromatographic Method for Determination of Formic acid Content in Isosulfan Blue and in Various Drugs

2021 ◽  
Vol 37 (2) ◽  
pp. 321-329
Author(s):  
Nilesh Takale ◽  
Neelakandan Kaliyaperumal ◽  
Gopalakrishnan Mannathusamy ◽  
Rajarajan Govindasamy
Keyword(s):  
Sulfuric Acid ◽  
Formic Acid ◽  
Chromatographic Method ◽  
Isopropyl Alcohol ◽  
Class Iii ◽  
Drug Substances ◽  
Headspace Gas ◽  
Concentrated Sulfuric Acid ◽  
Gas Chromatographic Method

The Pharmaceutical industry uses formic acid in the manufacturing of various drug substances or API. At the time of manufacturing of API formic acid is use as an oxidizing agent. Formic acid is the simplest carboxylic acid. It also called methanoic acid.Formic acid present in API at high concentrations is very hazardous but in low concentrations is very beneficial. The developed and validated method was short, precise, cost effective and reproducible with FID detector and easy to use. The method is a selective and superficial analytical method for determination of formic acid in different drug substances. We report here the development and validation study of headspace gas chromatographic method to determine formic acid in different drug substances we are reported here. As per this method, the drug sample was dissolved in 0.1% (v/v) of concentrated sulfuric acid in isopropyl alcohol (IPA) in a GC headspace vial and 0.1% (v/v) of concentrated sulfuric acid in isopropyl alcohol used as a diluent. A AB-Inowax capillary column (30 m x 0.32 mm I.D. and 0.5 µm film thickness) was used under gradient conditions with FID. The formic acid peak was well separated from all other solvents that are used in synthesis of particular drug substance. The LOD and LOQof the method for formic acid are 82 ppm and 249 ppm respectively. Formic acid are low toxic class-III solvent as per ICH guideline.

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