Analytical Method for the Development and Validation of Residual Solvents in Tigecycline by Gas Chromatography Using Headspace Sampling Technology

Syed Imam Pasha*, Shaik Liyaqat, M. Mushraff Ali Khan, Mohammed Abdul Farhan and Anupama Koneru

Department of Pharmaceutical Quality Assurance, Sultan-ul-Uloom College of Pharmacy Mount Pleasant, Banjara Hills, Hyderabad, Telangana, India.

Corresponding Author E-mail: impazam@gmail.com

DOI : http://dx.doi.org/10.13005/bbra/3280

ABSTRACT: Residual solvents such as Dichloromethane, Acetone, Methanol, and Isopropanol in pharmaceutical samples of Tigecycline were monitored using gas chromatography with headspace sampling technology. The column used for this elution is DB-624, 30m X 0.32mm X 1.8µm, Nitrogen is used as carrier gas with FID detector. Split ratio is 30:1 and the injector temperature is 210 °C. Estimation of the residual solvents is mandatory for the release testing of all active pharmaceutical ingredients (API). So, in this study, the authors estimated the four residual solvents of Tigecycline using the Headspace sampling technology, and the method is validated and meets all required standards per the ICH revised guidelines. So, this method can be used for routine analysis in Quality control laboratories for routine estimation.

KEYWORDS: GC-HS; Impurity profile; Residual solvents; Tigecycline

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