Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC

doi:10.19803/j.1672-8629.20230094

Abstract

Abstract: Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C18 column(250 mm×4.6 mm, 5μm) using. 0.02 mL·min-1 ammonium acetate solution-acetonitrile(95∶5, V/V) as mobile phase at a flow rate of 1.0 mL·min-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140~114.0 μg·mL-1（r=1.000 0）and 1.082~108.2 μg·mL-1（r=1.000 0）, respectively.The limit of quantification (LOD) were 0.220 9 ng and 0.202 1 ng, and the limit of quantification (LOQ) were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4% (n=9) and 100.7% with an RSD of 0.5% (n=9) .In 21 samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations.

Key words: paediatrics, liquid oral preparations, HPLC, bacteriostat, sodium benzoate, potassium sorbate, content

CLC Number:

R917

ZHOU Yuanhua, WU Liangyong, ZHANG Liwen, DONG Shunling, YAO Shangchen, XU Mingzhe, ZHANG Xianhua. Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 365-369.

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