两种高效液相色谱法检测盐酸克林霉素的比较

Comparison of two HPLC methods for determination of clindamycin hydrochloride

目的:改进中国药典盐酸克林霉素含量和有关物质检测的高效液相色谱法。方法:对比研究中国药典和欧洲药典高效液相色谱法得到的盐酸克林霉素色谱参数,并对欧洲药典方法进行了方法学验证。结果:中国药典方法不能将克林霉素主峰与杂质表克林霉素峰有效分离,一阶导数法纯度分析显示主峰不单一,主峰严重拖尾,杂质峰个数较少,且主峰理论塔板数不断降低,数针后即达不到分析要求。欧洲药典方法可将克林霉素主峰与杂质峰良好分离,方法学验证显示该法简单、方便、灵敏度高,专属性、重现性和耐用性良好。结论:建议修订中国药典盐酸克林霉素的含量和有关物质检测的高效液相色谱法。

OBJECTIVE To improve the HPLC method for determination of clindamycin hydrochloride in Chinese Pharmacopoeia. METHODS The chromatographic parameters of clindamycin hydrochloride by HPLC method in Chinese and European Pharmacopoeia were compared. The validation of HPLC method in European Pharmacopoeia was conducted. RESULTS Compared to method in European Pharmacopoeia, the chromatogram of clindamycin could not be completely separated from the chromatograms of impurities, the chromatogram numbers of impurities were very few, and the theory plates were fast decreasing to the prescribed minimum by method in Chinese Pharmacopoeia. The validation results showed that the method in European Pharmacopoeia is simple, with acceptable sensitivity, specificity, precision and accuracy. CONCLUSION The method in European Pharmacopoeia is suitable to suecessfully quantify clindamycin hydrochloride. It is advised to revise the HPLC method for determination of clindamycin hydrochloride in Chinese Pharmacopoeia.