title: Gas Chromatographic Method for the Quantitative Determination of a Hydrolytic Degradation Impurity in Busulfan Injectable Products.
abstract: An efficient and stability-indicating method has been developed and validated for the quantitative determination of tetrahydrofuran (THF), a hydrolytic degradation impurity, in Busulfan injectable pharmaceutical products by using gas chromatograph equipped with a liquid autosampler and a flame ionization detector. The chromatographic separation was performed on a fused silica capillary (Stabilwax; 60 m length × 0.32 mm i.d., 0.5 µm film thickness) column. The methodology was validated in accordance with regulatory guidelines. The proposed method was found to be specific, stable, precise, linear, accurate, robust, and rugged in the concentration range from 4 to 1,080 ppm for THF. The developed method was successfully applied to determine the THF content in Busulfan injectable pharmaceutical products.
authors.affiliation: Research and Development Centre, Bharathiar University, Coimbatore 641046, India.
authors.forename: H Ramakrishna
authors.initials: HR
authors.lastname: Reddy
authors.affiliation: Research and Development Centre, Department of Chemistry, Shridevi Institute of Engineering and Technology, Tumkur 572106, Karnataka, India.
authors.forename: N
authors.initials: N
authors.lastname: Chandrasekhar
authors.affiliation: Department of Biochemistry, Bangalore University, Bangalore 560001, Karnataka, India.
authors.forename: C S
authors.initials: CS
authors.lastname: Karigar