国内外苯扎氯铵的有关物质比较

Comparison of the Related Substances in Benzalkonium Chloride at Home and Abroad

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 benzalkonium chloride used as a pharmaceutical adjuvant, and com- pare the quality at home and abroad. Methods： An HPLC method was used with an ODS-HYPERSIL C18 column（250mm×4.6mm,5μm）. The detection wavelength was 210 nm and 257 nm. The flow rate was 1.0 ml .min -1and the column temperature was 30 ℃. The injection volume was 20 μl. The mobile phase was A （ dissolving 1.09 g sodiuml-hexanesulfonate and 6.9 g sodium dihydrogen phosphate in water, adjusting pH to 3.5 with phosphoric acid and diluting to 1 000.0 ml） and B （methanol） With gradient elution. Results： The content of benzaldehyde in the samples at home and abroad was low. The content of benzyl alcohol in the samples from a- broad was qualified, which was significantly higher than that in the domestic samples. The content of benzyl chloride in the domestic samples was higher than that in the samples from abroad. Conclusion： The method is simple and fast, which is suitable for comparing the related substances of domastic and imported samples. At the same time, the study provides basis for enterprises to choose benzalko- nium chloride rationally.