Determination of Residual Solvents in Bictegravir by Headspace Gas Chromatography

Sabiha Saba Hameed, Kudaravalli Sreedevi

Abstract: A modest and discerning headspace gas chromatography (HS-GC) method is defined for the determination & quantification of Residual Solvents in Bictegravir API. Chromatographic parting was achieved on a D-B-624 column, (30mx0.53mm) 3.0micron column using various temperature gradients of Flame Ionisation Detectors (FID). Linearity in the series 50-150µg/ml using Methanol, Dimethyl formamide (DMF), Tetrahydrofuran, Dichloromethane and Acetonitrile (r2>0.999) as solvents. The proposed methods were validated. Accuracy assessed by recovery studies at 3 diverse levels. Recovery experiments showed that diluent and API not interfered. The technique was found to be precise as indicated by the repeatability analysis, showing %RSD less than 10 for Methanol, DMF, Tetrahydrofuran, Dichloromethane and Acetonitrile. Therefore, it proves validity of the procedures and shall be utilised for routine study of pharmaceutical active ingredients for valuation of Residual Solvents of Methanol, DMF, Tetrahydrofuran, Dichloromethane and Acetonitrile in Bictegravir.

Keywords: HS-GC, Residual solvents, Bictagravir, FID, Tetrahydrofuran

How to Cite?: Sabiha Saba Hameed, Kudaravalli Sreedevi, "Determination of Residual Solvents in Bictegravir by Headspace Gas Chromatography", Volume 8 Issue 8, August 2019, International Journal of Science and Research (IJSR), Pages: 1513-1520, https://www.ijsr.net/getabstract.php?paperid=ART2020632, DOI: https://dx.doi.org/10.21275/ART2020632