摘要
目的建立法莫替丁中甲醇、丙酮和乙醇残留量的测定方法。方法采用毛细管气相色谱法,色谱柱为HP-Wax;柱温:50℃保持3min,以20℃/min升温至120℃保持4min;载气为氮气;检测器为FID;外标法计算含量。结果在该色谱条件下,测得各溶剂线性均良好(r=0.9996～0.9997);平均回收率分别为97.86%,98.16%和98.04%,RSD分别为1.34%,1.21%和0.94%;甲醇、丙酮和乙醇的最低检测限分别为0.004%、0.002%和0.004%;3批样品中上述有机溶剂残留量均符合要求。结论该毛细管气相色谱法灵敏、准确、可靠,适用于本品中有机溶剂残留量测定。
Objective To establish the analysis methods for the residual methanol, acetone and ethanol in famotidine samples with capillary gas chromatography. Methods Commercially available and self-prepared famotidine samples were analyzed on an HP5890 gas chromatograph using flame ionization detector with a capillary column (30 m×0.32 mm×0.50μm). Results good linear correlations were obtained during the detection(r=0.9996-0.9997). The average recoveries were 97.86%(RSD 1.34%, n=3),98.16%(RSD 1.21%, n=3) and 98.04%(RSD 0.94%, n=3 ) for methanol, acetone and ethanol, respectively. The limits of quantification for methanol, acetone an ethanol were 0.004%, 0.002% and 0.004%, respectively. The contents of the residual solvents in three batches of products were acceptable. Conclusion the method is reliable and can be applicable in the detection of residual methanol, acetone and ethanol in famotidine samples.
出处
《广东药学院学报》
CAS
2005年第3期265-266,共2页
Academic Journal of Guangdong College of Pharmacy
