论文部分内容阅读
目的:建立苄星青霉噻唑酸有关物质测定的梯度洗脱HPLC法。方法:采用端基封尾的C18柱,流动相A为0.05mol/L磷酸二氢钾溶液(用磷酸调节p H值至3.1),流动相B为甲醇,流速1.0m L·min-1,线性梯度洗脱,检测波长220nm,柱温40℃。结果:苄星青霉噻唑酸分别与相邻杂质峰分离完全,检测限为3ng,定量限为11ng。结论:本法专属、灵敏,精密度和耐用性良好,可作为苄星青霉噻唑酸有关物质和色谱纯度的测定方法。
OBJECTIVE: To establish a gradient elution HPLC method for the determination of related substances of penicillin benzathine. Methods: A C18 column with end-capped end was used. The mobile phase A was 0.05 mol / L potassium dihydrogen phosphate solution (pH value was adjusted to 3.1 by phosphoric acid), the mobile phase B was methanol and the flow rate was 1.0 m L · min-1. Linear gradient elution, detection wavelength 220nm, column temperature 40 ℃. Results: Benzathine penicillin was completely separated from the adjacent impurity peak, the detection limit was 3ng and the limit of quantitation was 11ng. Conclusion: This method is specific, sensitive, precise and durable good, can be used as a method of determination of thiazole acid substances and chromatographic purity of benzathine penicillin.