摘要
为验证清洁操作完成后,硫酸镁钠钾口服用浓溶液在生产设备表面的残留量是否低于残留限度,文章通过离子色谱法来测定残留物中硫酸根离子的含量。以Dionex IonPacTM AS11-HC柱为色谱柱,Dionex IonPacTM AG11-HC柱为保护柱,以20 mmol/L氢氧化钾溶液为淋洗液,流速为1.0m L/min,进样体积为10μL,抑制器为ADRS 600(4 mm),抑制电流为50 m A。硫酸根离子质量浓度在0.03~149.18μg/mL范围内线性关系良好(r=1.00,n=7),定量限浓度为0.030μg/mL,检测限质量浓度为0.0072μg/mL,各材料平板的取样回收率均大于70%,S_(RSD)值低于20%。该检测方法操作便捷、结果准确、灵敏度高、专属性强,适用于对生产设备清洁验证中残留物硫酸根离子的快速定量分析。
To verify if the residue of magnesium sulfate,sodium sulfate and potassium sulfate concentrate oral solution on the cleaning surface was below the safe limit,an ion chromatography method was established for the determination of residue sulfate ions.The chromatographic column was Dionex IonPacTM AS11-HC column,the guard column was Dionex IonPacTM AG11-HC;the eluent was 20 mmol/L potassium hydroxide solution;the flow rate was 1.0 mL/min;the injection volume was 10μL and suppressor conductivity detector was ADRS 600(4 mm),and current value was 50 mA.There was good linear relationship between sulfate ions at 0.03-149.18μg/ml(r=1.00,n=7).The limit of quantification(LOQ)was 0.030μg/ml,and the limit of detection(LOD)was 0.0072μg/mL.The recovery rate of each material was greater than 70%,and the S_(RSD) value was lower than 20%.The established method is convenient,accurate,highly sensitive and specific,which can be used for rapid quantitative analysis of sulfate ions residues in the cleaning validation of production equipment.
作者
姚静静
臧晓红
YAO Jingjing;ZANG Xiaohong(Yangztze River Pharmaceutical Group,Taizhou 225321,China)
出处
《工业微生物》
CAS
2024年第2期134-136,共3页
Industrial Microbiology
关键词
离子色谱法
硫酸根离子
清洁验证
ion chromatography
sulfate ion
cleaning validation
