TOC法测定清洁验证中盐酸林可霉素残留量

Determination of lincomycin hydrochloride residue in cleaning verification by TOC method

目的 :验证总有机碳法测定盐酸林可霉素清洁残留物的准确性。方法 :根据总有机碳法中测定值与浓度正相关的特性来判定林可霉素残留量。结果 :该检验方法在0.5~2.0μg/ml浓度范围有较好的线性关系,相关系数R2=0.998 6,检测限与定量限分别为0.504 9和1.530 3μg/ml,最低擦拭回收率为73.5%。结论:该方法简便、快捷、准确,适合林可霉素注射液生产结束清洁后残留量的检测。

Objective:To validate the accuracy of determination of lincomycin hydrochloride residue after cleaning by total organic carbon(TOC)method.Methods:The residue concentrations were determined based on the positive correlation between the measured value and the concentration in the TOC method.Results:A good linear relationship was shown when lincomycin hydrochloride concentrations were in the range of 0.5-2.0 mg/ml,with correlation coefficient R2=0.9986.The limits of detection and quantification were 0.5049 and 1.5303 mg/ml,with minimum wipe recovery rate 73.5%.Conclusion:This method is simple,quick and accurate and is suitable for the detection of the cleaning residue after lincomycin hydrochloride production.