摘要
为建立离子色谱法测定聚卡波非钙片中的钙含量,进一步提高药品质量控制标准。本研究采用离子色谱法,选用Metrosep C6-150/4.0色谱柱,以1.2 mmol/L草酸溶液-3.6 mmol/L硝酸溶液(1∶1)为洗脱液,流速1.2 mL/min,柱温30℃,进样量20μL,电导检测器,测定聚卡波非钙片中钙的含量。结果显示,钙在2.5μg/mL~15μg/mL与峰面积呈良好线性关系,相关系数r=0.9997,仪器精密度RSD为0.4%,平均加样回收率为99.49%,供试品溶液在24 h内稳定。该法操作简便快捷,灵敏度高,准确性佳,重复性好,为提高聚卡波非钙片质量标准提供科学理论依据。
To establish an ion chromatography method for the determination of calcium in calcium polycarbophil tablets so as to further improve the quality control standard of drugs.Ion chromatography was performed on a Metrosep C6-150/4.0 column,with 1.2 mmol/L oxalic acid solution-3.6 mmol/L nitric acid solution(1∶1)as eluent at a flow rate of 1.2 mL/min.The column temperature was 30℃,the injection volume was 20μL,and a conductivity detector was used to determine the content of calcium in calcium polycarbophil tablets.The results showed that the calcium content in the range of 2.5μg/mL-15μg/mL had a good linear relationship with the peak area,with a correlation coefficient(r)of 0.9997 and an instrumental precision RSD of 0.4%.The average recovery rate was 99.49%,and the stability test showed that the solution remained stable within 24 h.The method is simple,rapid,sensitive,accurate,and reproducible.It can provide a scientific basis for improving the quality standard of calcium polycarbophil tablets.
作者
林康来
黄思睿
LIN Kanglai;HUANG Sirui(Maoming Institute for Food and Drug Control,Maoming Guangdong,525000,China)
出处
《质量安全与检验检测》
2025年第6期50-53,共4页
QUALITY SAFETY INSPECTION AND TESTING
关键词
离子色谱法
聚卡波非钙片
钙含量
Ion chromatography
Calcium polycarbophil tablets
The content of calcium
