scholarly journals Development and Validation of an Analytical Method for Simultaneous Quantitation of Organic Volatile Impurities in Technical-Grade Active Ingredients of Pesticides and Agrochemicals by Headspace Gas Chromatography

2015 ◽  
Vol 36 (2) ◽  
pp. 67-71
Author(s):  
Masato KAZUSAKI ◽  
Satoshi OKUMURA ◽  
Kozo KITA ◽  
Makiko MUKUMOTO ◽  
Masahiko OKAMOTO
Keyword(s):  
Gas Chromatography ◽  
Analytical Method ◽  
Headspace Gas Chromatography ◽  
Active Ingredients ◽  
Technical Grade ◽  
Headspace Gas ◽  
Development And Validation ◽  
Volatile Impurities

scholarly journals Establishment for analytical method of methanol in wet wipes by headspace gas chromatography

2016 ◽  
Vol 29 (5) ◽  
pp. 242-247 ◽  
Author(s):  
Yongkyu Choi ◽  
Eunji Baek ◽  
Chungsik Min ◽  
Rheeda Lee ◽  
Soonyoung Park ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Analytical Method ◽  
Headspace Gas Chromatography ◽  
Headspace Gas

scholarly journals A headspace-gas chromatography method for isopropanol determination in warfarin sodium products as a measure of drug crystallinity

2018 ◽  
Vol 68 (1) ◽  
pp. 31-46 ◽  
Author(s):  
Ziyaur Rahman ◽  
Sohail Akhtar ◽  
Akhtar Siddiqui ◽  
Anthony B. Ciavarella ◽  
Agnes Nguyenpho ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Calibration Curve ◽  
Analytical Method ◽  
Drug Product ◽  
Internal Standard ◽  
Good Resolution ◽  
Headspace Gas Chromatography ◽  
Indirect Measure ◽  
Warfarin Sodium ◽  
Headspace Gas

Abstract Coumadin® a nd s everal generic products of warfarin s odium (WS) contain the crystalline form (clathrate) in which WS and isopropanol (IPA) are associated in a 2:1 molar ratio. IPA is critical in maintaining the WS crystalline structure. Physicochemical properties of the drug and drug product may change when the crystalline drug transforms to amorphous form. A headspace-gas chromatography (HS-GC) method was developed and validated for IPA determination in the WS drug product. n-propanol (NPA) was used as internal standard and the method was validated for specificity, system suitability, linearity, accuracy, precision, range, limits of detection and quantification, and robustness. The method was specific, with good resolution between IPA and NPA peaks. Chromatographic parameters (retention time, IPA/NPA area ratio, tailing factor, theoretical plates, USP symmetry, capacity factor, selectivity and resolution) were consistent over three days of validation. The analytical method was linear from 2-200 μg mL-1 (0.1- 10 % IPA present in the drug product). LOD and LOQ were 0.1 and 2 μg mL-1, respectively. Accuracy at low (2 μg mL-1) and high (200 μg mL-1) IPA concentrations of the calibration curve was 103.3-113.3 and 98.9-102.2 % of the nominal value, resp. The validated method was precise, as indicated by the RSD value of less than 2 % at three concentration levels of the calibration curve. The method reported here was utilized to determine accurately and precisely the IPA content in in-house formulations and commercial products. In summary, IPA determination by HS-GC provides an indirect measure of WS crystallinity in the drug product. Nevertheless, it should be confirmed by another analytical method since IPA from the drug substance is not distinguishable from IPA that may be present outside the drug crystals in a dosage form when prepared by wet granulation with IPA.

scholarly journals Development and validation of residual solvent determination by headspace gas chromatography in Imatinib Mesylate API

2019 ◽  
Vol 1 (3) ◽  
Author(s):  
Chandrakant Sojitra ◽  
Ajay Tehare ◽  
Chintan Dholakia ◽  
Padmaja Sudhakar ◽  
Sameer Agarwal ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Imatinib Mesylate ◽  
Headspace Gas Chromatography ◽  
Residual Solvent ◽  
Headspace Gas ◽  
Development And Validation
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