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目的:对药用辅料苯扎氯铵中的有关物质进行测定并比较国内外样品的内在质量。方法:采用高效液相色谱梯度洗脱法,色谱柱:ODS-HYPERSIL C18柱(250 mm×4.6 mm,5μm);检测波长:210 nm和257 nm(采用PDA检测器);流速:1.0 ml·min~(-1);柱温:30℃;进样体积:20μl;流动相:A(取己烷磺酸钠1.09 g及磷酸二氢钠6.9 g加水稀释至1 000 ml,摇匀,用磷酸调节p H至3.5)-B(甲醇)。结果:国内外样品的苯甲醛残留均较低;国外样品中苯甲醇残留合格,但明显高于国内样品;国内样品中氯化苄含量较高。结论:该方法快速、简便,可用于比较国内外样品中的有关物质,同时为企业合理选择苯扎氯铵提供依据。
OBJECTIVE: To determine the related substances in medicinal excipients benzalkonium chloride and compare the intrinsic quality of domestic and foreign samples. METHODS: High performance liquid chromatography with gradient elution was used. The column was ODS-HYPERSIL C18 (250 mm × 4.6 mm, 5 μm). The detection wavelength was 210 nm and 257 nm with a PDA detector. The flow rate was 1.0 ml. min -1; Column temperature: 30 ℃; Injection volume: 20μl; Mobile phase: A (Take sodium hexanesulfonate 1.09 g and sodium dihydrogen phosphate 6.9 g and dilute to 1 000 ml with water, Phosphoric acid adjusts p H to 3.5) -B (methanol). Results: The benzaldehyde residues were low in domestic and foreign samples. The residues of benzyl alcohol in foreign samples were qualified, but were significantly higher than those in domestic samples. The content of benzyl chloride in domestic samples was high. Conclusion: The method is rapid and simple, and can be used to compare the related substances in domestic and foreign samples, at the same time provide the basis for the rational selection of benzalkonium chloride.