菲啰嗪柱前衍生联合高效液相色谱法测定麦芽酚铁胶囊中痕量Fe(Ⅱ)  

Determination of trace Fe(Ⅱ) in ferric maltol capsules by pre-column derivatization with Ferrozine combined with high-performance liquid chromatography

作　　者：李波[1,2] 杨欢 旷文俊 LI Bo;YANG Huan;KUANG Wenjun(Pharmaceutical Research and Development Center,Livzon Group Limin Pharmaceutical Factory,Guangdong Shaoguan 512028,China;Guangdong Provincial Key Laboratory of R&D and Industrialization of High-end Liquid Pharmaceutical Preparations,Guangdong Shaoguan 512028,China)

机构地区：[1]丽珠集团利民制药厂医药研究所,广东韶关512028 [2]广东省高端液体药物制剂研发及产业化企业重点实验室,广东韶关512028

出　　处：《中国医院药学杂志》2025年第2期148-151,共4页Chinese Journal of Hospital Pharmacy

基　　金：2023年度韶关市支持科技工作者项目(编号:230331148038404)

摘　　要：目的:建立一种高效液相色谱法(HPLC)用于测定麦芽酚铁胶囊中Fe(Ⅱ)的含量,并进行方法学验证。方法:采用月旭Ultimate^(R)LP-C8色谱柱(4.6 mm×250 mm,5μm)进行分离,以pH 7.0菲啰嗪缓冲液∶乙腈∶四氢呋喃(V/V/V,98.8∶1.0∶0.2)-乙腈(V/V,80∶20)为流动相进行洗脱;进样体积为5μL;检测波长为561 nm;柱温为30℃;流速为1 mL·min^(–1)。结果:准确度和精密度均符合要求,检出限与定量限分别为0.045、0.075μg·mL^(–1),检测浓度在0.075~2.55μg·mL^(–1)内线性关系良好;耐用性、溶液稳定性(18.5 h内)结果也均符合要求。结论:该研究首次采用HPLC技术直接测定麦芽酚铁胶囊中Fe(Ⅱ)含量。该检测方法准确度和精密度高,灵敏度好,可用于补铁剂的工艺开发和质量控制。OBJECTIVE To establish a high-performance liquid chromatography(HPLC) method for the determination of Fe(Ⅱ) in ferric maltol capsules,and to verify the method.METHODS The separation was performed on the Ultimate^(R) LP-C8 column(4.6 mm×250 mm,5 μm),and elution was performed with pH 7.0 TRIS-Ferrozine buffer.Acetonitrile:tetrahydrofuran(98.8∶1.0∶0.2)-acetonitrile(80∶20) was used as the mobile phase.The injection volume was 5 μL.The detection wavelength was 561 nm.The column temperature was 30 ℃.The flow rate was 1 mL·min^(–1).RESULTS The accuracy and precision met the requirements.The limits of detection and quantification were 0.045 μg·mL^(–1) and 0.075 μg·mL^(–1),respectively.The linear relationship was good with the range of 0.075-2.55 μg·mL^(–1).The results of durability and solution stability(stable within 18.5 h) also met the requirements.CONCLUSION We for the first time suggested that the content of Fe(Ⅱ) in ferric maltol capsules is directly determined by HPLC.The method has high accuracy,precision and sensitivity,and can be used for process development and quality control of iron supplement.

关 键 词：亚铁离子含量测定 麦芽酚铁胶囊 补铁产品 高效液相色谱法 质量标准 

分 类 号：R917[医药卫生—药物分析学]