HPLC法测定复方阿达帕林盐酸克林霉素凝胶中盐酸克林霉素有关物质

Determination of related substances of clindamycin hydrochloride in compound adapalene and clindamycin hydrochloride gel by HPLC

目的:建立HPLC法测定复方阿达帕林盐酸克林霉素凝胶中盐酸克林霉素的有关物质。方法:采用C18色谱柱(250 mm×4.6 mm,5μm),以磷酸二氢钾溶液为流动相A,乙腈为流动相B进行梯度洗脱,流速0.8 mL·min^(-1),柱温30℃,在210 nm紫外波长条件下进行检测。结果:4种已知杂质的分离度(林可霉素2.88,克林霉素B 6.73,7-差向克林霉素5.66,7-表林可霉素32.05)和其余未知杂质以及克林霉素的分离度均大于1.5。结论:本法专属性好,使复方制剂中的各个辅料与主成分及有关物质实现有效分离,可以更准确测定复方凝胶中盐酸克林霉素的有关物质。

Objective：To establish an HPLC method for the determination of the related substances of clindamycin hydrochloride in compound adapalene and clindamycin hydrochloride gel.Methods：C18 column（250 mm×4.6 mm,5 μm）was used,the mobile phase consisted of potassium dihydrogen phosphate solution（A）and acetonitrile（B）in gradient elution manner,the flow rate was 0.8 mL·min^-1,the column temperature was 30 ℃,and the detection wavelength was 210 nm.Results：The resolutions of the four known impurities（lincomycin 2.88,clindamycin B 6.73,7-epimeric clindamycin 5.66,7-epi-lincomycin 32.05）and unknown impurities were well separated.The resolutions between the main peak and the peak of impurities were all greater than 1.5.Conclusion：The method has good specificity and can effectively separate the auxiliary materials,main component and the related substances in the compound.This method can be used to determine the related substances of clindamycin hydrochloride in the compound gel.