Reddy H Ramakrishna, Chandrasekhar N, Karigar C S
Research and Development Centre, Bharathiar University, Coimbatore 641046, India.
Research and Development Centre, Department of Chemistry, Shridevi Institute of Engineering and Technology, Tumkur 572106, Karnataka, India.
J Chromatogr Sci. 2016 Oct 17;54(9):1475-1480. doi: 10.1093/chromsci/bmw117.
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.
已开发并验证了一种高效且具有稳定性指示作用的方法，用于定量测定白消安注射剂药品中的水解降解杂质四氢呋喃（THF），该方法采用配备液体自动进样器和火焰离子化检测器的气相色谱仪。色谱分离在熔融石英毛细管（Stabilwax；长度60 m×内径0.32 mm，膜厚0.5 µm）柱上进行。该方法按照监管指南进行了验证。结果表明，所提出的方法在THF浓度范围为4至1080 ppm时具有特异性、稳定性、精密度、线性、准确性、稳健性和耐用性。所开发的方法已成功应用于测定白消安注射剂药品中的THF含量。
