Determination of related substances of vitamin B2 in compound zinc, iron and calcium oral solution by HPLC

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Author:  LI Qi ^1, ^2, ³ LI Xiaoyan ⁴ LIU Yanming ^1, ^2, ³ SHU Sen ⁵ LI Yuxin ^1, ³

Affiliation: 1. Hunan Institute for Drug Control, Changsha 410001, China 2. Key Laboratory of Pharmaceutical Excipients Engineering Technology Research, National Medical Products Administration, Changsha 410001, China 3. Hunan Engineering Technology Research Center for Drug Quality Evaluation, Changsha 410001, China 4. Hunan Drug Inspection Center, Changsha 410001, China 5. Yueyang Hudex Pharmaceuticals Ltd., Yueyang 414022, Hunan Province, China

Keywords: Compound zinc iron and calcium oral solution Vitamin B2 Related substances High performance liquid chromatography

DOI: 10.12173/j.issn.2097-4922.202409055

Reference: LI Qi, LI Xiaoyan, LIU Yanming, SHU Sen, LI Yuxin. Determination of related substances of vitamin B2 in compound zinc, iron and calcium oral solution by HPLC[J]. Yaoxue QianYan Zazhi, 2025, 29(2): 236-242. DOI: 10.12173/j.issn.2097-4922.202409055.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To establish a method for the determination of related substances of vitamin B₂ in compound zinc, iron and calcium oral solution.

Methods The chromatographic column was Ultimate XB-C₁₈ column (250 mm×4.6 mm, 5 μm). The mobile phase was 1% phosphoric acid solution (with pH of triethylamine adjusted to 3.5 ) and acetonitrile with gradient elution. The detection wavelength was 260 nm, the flow rate was 1.0 mL/min, the column temperature was 40 ℃, and the injection volume was 20 μL.

Results This method could effectively separate vitamin B₂ and its degraded impurities, lumichrome and lumiflavin. The linear range was 0.119-3.594 μg/mL for vitamin B₂ (r=1.000 0), 0.115-3.479 μg/mL for lumichrome (r=1.000 0), and 0.114-3.435 μg/mL for lumiflavin (r=0.999 9). The correction factors of lumiflavin and lumichrome were 0.7 and 1.0 respectively.

Conclusion This method has strong specificity, simple operation, high sensitivity and good repeatability, can effectively determine the degradation impurities of vitamin B₂ in compound zinc, iron and calcium oral solution, and provide technical support for improving drug quality and reducing medication risks.

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