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Research Paper | Pharmaceutical Science | India | Volume 8 Issue 8, August 2019

Determination of Residual Solvents in Teneligliptin by Head Space Gas Chromatography

Zainab Hussain | V. Murali Balaram

Abstract: A simple and selective HS-GC method is described for the determination & quantification of Residual Solvents in Teneligliptin API. Chromatographic separation was achieved on a DB-624 column, (30mx0.53mm) 3.0µm column using different temperature gradient of FID Detectors. Linearity was observed in the range 50-150 µg /ml for Methanol, Dimethyl formamide, Tetrahydrofuran, Dimethyl acetamide and 1, 4 Dioxane (r2>0.999) for the amount of solvent estimated by the proposed methods was in good agreement. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered diluent and API. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 10 for Methanol, Dimethyl formamide, Tetrahydrofuran, Dimethyl acetamide and 1, 4 Dioxane. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical active ingredients for estimation of Residual Solvents of Methanol, DMF, THF, THF, DMA and 1, 4 Dioxane in Teneligliptin.

Keywords: HS-GC, Teneligliptin, residual solvents, dimethyl acetamide, flame ionization detector

Edition: Volume 8 Issue 8, August 2019,

Pages: 2115 - 2122