Development and validation of a stability-indicating gas chromatographic method for quality control of residual solvents in blonanserin: A novel atypical antipsychotic agent
Blonanserin is a novel atypical antipsychotic agent. So far, there has not been any literature available to simultaneously determine its residual ethyl alcohol, isopropyl alcohol and toluene in this bulk drug substance. Thus, a gas chromatographic method for the determination of residual solvents was developed and validated in this paper. Quantitation was performed by external standard analyses and the method was shown to be specific (no interference in the blank solution), linear (correlation coefficients ≥0.99998), sensitive (limit of detections ≤0.2ng, and limit of quantitations ≤ 0.7ng), accurate (average recoveries between 94.1％ and 101.7％), precise (intra- and inter-day precision ≤2.6％) and stable (reference standard and sample solutions are stable over 48hrs). This extensively validated method is ready to be used for the quality control of blonanserin.
Gas chromatography Residual solvents Method development Method validation Blonanserin
Ming Peng Jin Liu Dan Lu Yong-Jian Yang
Department of Chemistry, Shanghai Institute for Food and Drug Control, 201203 Shanghai, China
国内会议
烟台
英文
1-15
1900-01-01（万方平台首次上网日期，不代表论文的发表时间）