篇名: HPLC法测定强力枇杷露中苯甲酸钠的含量
摘要: 目的:建立测定强力枇杷露中苯甲酸钠含量的方法,为提高该制剂质量标准提供参考。方法:采用高效液相色谱法。色谱柱为Shimadzu VP-ODS C18,流动相为甲醇-0.02%乙酸铵(15 ∶ 85,V/V),流速为1.0 ml/min,检测波长为224 nm,柱温为40 ℃,进样量为5 μl。使用该方法对21家生产企业的56批次强力枇杷露中苯甲酸钠的含量进行测定。结果:苯甲酸钠检测质量浓度线性范围为0.005 24~1.048 00 mg/ml(r=0.999 9);精密度、稳定性、重复性试验的RSD≤1.10%;加样回收率为98.6%~101.7%,RSD=1.2%(n=6)。56批次强力枇杷露中苯甲酸钠的含量差异较大,但总体均符合2015年版《中国药典》(四部)糖浆剂下要求。结论:该方法操作简单、结果准确、重复性好,可用于强力枇杷露中苯甲酸钠的含量测定。抽样测定结果表明,有必要更新该制剂的含量检测项目,以利于其质量控制。
ABSTRACT: OBJECTIVE:To establish a method for the content determination of sodium benzoate in Qiangli pipa syrup, and provide reference for improving the quality standard of preparation. METHODS: HPLC was performed on the column of ShimadzuVP-ODS C18 with mobile phase of methanol-0.02% ammonium acetate (15 ∶ 85,V/V) at a flow rate of 1.0 ml/min,the detection wavelength was 224 nm, column temperature was 40℃, and the injection volume was 5 μl. The method was used to determine the content of sodium benzoate in 56 batches of Qiangli pipa syrup from 21 manufacturers. RESULTS:The linear range of sodium benzoate was 0.005 24-1.048 00 mg/ml(r=0.999 9); RSDs of precision, stability and reproducibility tests were no more than 1.10%; recovery was 98.6%-101.7% (RSD=1.2%,n=6). It showed big difference in the content of sodium benzoate in the 56 batches of Qiangli pipa syrup, but it generally met the requirements of syrups in Chinese Pharmacopoeia (2015 edition, VolⅣ). CONCLUSIONS: The method is simple, rapid, accurate and reliable with good reproducibility, and can be used for the content determination of sodium benzoate in Qiangli pipa syrup. Determination results of sampling show it is necessary to update the formulation content detection projects to strengthen their quality control.
期刊: 2016年第27卷第9期
作者: 胡卫南
关键字: 高效液相色谱法;强力枇杷露;苯甲酸钠;含量测定
KEYWORDS: HPLC; Qiangli pipa syrup; Sodium benzoate; Content determination
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