马来酸桂哌齐特残留溶剂检查方法的建立

目的建立马来酸桂派齐特原料药溶剂残留的测定方法。方法采用项空进样气相色谱法，通过内标法以峰面积比计算来测定马来酸桂派齐特溶剂残留，并进行系统的方法学研究。结果本测定方法的系统适应性较好；线性关系测定结果表明，各溶剂浓度与其峰面积和内标丁酮的比值成良好的线性关系；测定方法定量限分别为丙酮8．5ng、乙醇101．4ng、二氯甲烷11．3ng；准确度试验好，丙酮的平均回收率为100．6％，RSD=1．12％、二氯甲烷的平均回收率为100．3％，RSD=I．39％、乙醇的平均回收率为99．7％，RSD=I．28％。结论内标法以峰面积比计算来测定马来酸桂派齐特溶剂残留，准确度好，适用于马来酸桂派齐特溶剂残留的检查。

Establishment ofCinepazide Maleate Residual Solvent Testing Method

Objective To establish a method for determination of Cinepazide Maleate API residual solvent. Method Using headspace gas chromatography by the internal standard method with peak area ratio calculations to deter- mine Cinepazide Maleate solvent residue and a systematic methodology study was conducted. Results The system suitability determination method is better; The linear relationship between the measured results showed that a good linear relationship was obtained in the concentration of the solvent and its internal standard peak area ratio of bu- tanone; determination method limit of quantitation were acetone 8.5ng, ethanol 101.4ng, dichloromethane 11.3ng; accuracy test is good, the average recovery of acetone was 100.6% RSD = 1.12%, the average recovery of dichloromethane 100.3% RSD = 1.39%, the average recovery of ethanol was 99.7% RSD = 1.28 %. Conclusion The internal standard method with peak area ratio calculations to determine Cinepazide Maleate solvent residue and good accuracy for dispatch Cinepazide Maleate solvent residue checks.