Ingredient Analysis

Determination of sucrose and monosaccharide in dextromethorphan hydrobromide and guaifenesin syrup

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  • Xiamen Institute for Food and Drug Control, Xiamen 631102, China

Received date: 2023-02-28

  Online published: 2024-06-21

Abstract

Objective: To establish a method for the quantitative analysis of fructose, glucose and sucrose in dextromethorphan hydrobromide and guaifenesin syrup by HPLC with differential refractive index detector (HPLC-RID) and to evaluate the quality of the syrup based on the content of these sugars. Methods: The optimal condition for separation and detection was achieved on a NH2 column with the mobile phase of water-acetonitrile (25∶75). The column temperature was 40 ℃. The flow rate was 1 mL·min-1. And the injection volume was 20 μL. Results: Under the chromatographic conditions, fructose, glucose, sucrose and maltose could be well separated. The linear ranges of fructose, glucose, sucrose were 1.515-30.3 mg·mL-1, 3.52-70.4 mg·mL-1 and 4.462-89.240 mg·mL-1, respectively. The recoveries were 99.3%-101.1%,RSD<2.0%. Seventy-three batches of samples from three manufacturers were inspected. No sucrose adulterated maltose was found. However, fourteen batches of samples contained sucrose less than 45%(g·mL-1), which is the minimum limit of the amount of sucrose in syrup in Chinese Pharmacopoeia. The defective rate was 19.4%. Degradation of sugars at lower pH might be the reason for the disqualification. Conclusion: This stable and simple method could not only be used for the determination of sucrose and its inverted sugars, but also for the screening of maltose illegal feeding. It is suggested to tighten the pH of dextromethorphan hydrobromide and guaifenesin syrup to 4-5. This will reduce the degradation rate of sucrose and stabilize the quality of the drug.

Cite this article

WANG Ya-jun, TANG Li-chao, XU Yong-bin, ZHENG Shu-feng . Determination of sucrose and monosaccharide in dextromethorphan hydrobromide and guaifenesin syrup[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(12) : 2066 -2071 . DOI: 10.16155/j.0254-1793.2023.12.11

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