HPLC法测定并比较药用级与非药用级苯甲酸钠的含量
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篇名: HPLC法测定并比较药用级与非药用级苯甲酸钠的含量
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摘要: 目的:建立测定并比较药用级(药用辅料和原料药)与非药用级(化学试剂和食品添加剂)苯甲酸钠含量的方法。方法:  采用高效液相色谱法测定含量,并采用SPSS 18.0软件对含量测定结果进行统计和比较。色谱柱为Purospher STAR LP RP-18 endcapped,流动相为乙腈-0.02%甲酸(用氨水调pH至4.0)(30 ∶ 70,V/V),流速为1.0 ml/min,检测波长为230 nm,柱温为35 ℃,进样量为20 μl。结果:苯甲酸钠检测质量浓度线性范围为10.5~525.3 μg/ml(r=0.999 9);精密度、稳定性、重复性、耐用性试验的RSD<0.5%;加样回收率为99.38%~101.26%(RSD=0.56%,n=9)。药用级与非药用级样品含量均值在99.400%~99.875%之间,非药用级样品含量均值低于药用级。结论:该方法准确、简便、专属性强、重复性好,可用于药用级与非药用级苯甲酸钠的含量测定和比较。
ABSTRACT: OBJECTIVE: To establish a method to determine and compare the contents of sodium benzoate in medicinal (pharmaceutical excipients and active pharmaceutical ingredients) and non-medicinal (chemical reagents and food additives) grade. METHODS: HPLC was conducted for content determination, SPSS 18.0 software was adopted to compare the results. The column was Purospher STAR LP RP-18 endcapped with mobile phase of acetotrile-0.02% formic acid (adjusted pH to 4.0 with aqua ammonia) (30 ∶ 70,V/V) at a flow rate was 1.0 ml/min, the detection wavelength was 230 nm, column temperature was 35 ℃, and volume injection was 20 μl. RESULTS: The linear range of sodium benzoate was 10.5-525.3 μg/ml (r=0.999 9); RSDs of precision, stability, reproducibility and durability tests were lower than 0.5%; recovery was 99.38%-101.26% (RSD=0.56%,n=9). The average contents of sodium benzoate in medicinal and non-medicinal grade were between 99.400%-99.875%, but the average content of non-medicinal grade is lower than the medical grade. CONCLUSIONS: The method is accurate and simple with high specificity and good reproducibility, and can be used to determine and compare the content of sodium benzoate in medicinal and non-medicinal grade.
期刊: 2016年第27卷第18期
作者: 粟贵,刘雁鸣,龙海燕,李颖,廖彬
AUTHORS: SU Gui,LIU Yanming,LONG Haiyan,LI Ying,LIAO Bin
关键字: 高效液相色谱法;苯甲酸钠;药用级;非药用级;含量;比较
KEYWORDS: HPLC; Sodium benzoate; Medicinal; Non-medicinal; Content; Comparison
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