不同药典中盐酸林可霉素含量及有关物质测定方法的比较研究

Comparison of assay and related substances of lincomycin hydrochloride in the different pharmacopoeias

目的:对《中国药典》2020年版、《欧洲药典》10.0版(EP 10.0)、《美国药典》43版(USP 43)中盐酸林可霉素含量及有关物质检测方法进行分析比较,通过试验考察不同国家药典检测盐酸林可霉素含量及有关物质结果的差异,为我国盐酸林可霉素质量标准的修订和完善提供参考。方法:比较《中国药典》2020年版、EP 10.0、USP 43三种药典中盐酸林可霉素含量及有关物质检测过程中色谱条件(色谱柱、流动相、波长、进样体积、流速)、对照品溶液和供试品溶液制备方法、限度标准方面的差异。结果:《中国药典》2020年版方法中色谱柱使用较常用的C_(18)柱,柱子耐用性好但对杂质检测灵敏度低;EP 10.0方法对杂质的控制更全面,不仅对单杂、总杂进行控制还对三个特定杂质进行了控制,而USP 43没有对该品种的有关物质控制进行规定。3种不同药典测得盐酸林可霉素的含量由于以不同的成分计而结果不同。结论:中、美、欧三种药典中关于盐酸林可霉素含量测定的色谱条件差异不大,但EP 10.0中对盐酸林可霉素杂质的控制更加完善,可为《中国药典》盐酸林可霉素标准修订和完善提供重要参考。

Objective:To compare the assay and related substances of lincomycin hydrochloride in the Chinese Pharmacopoeia 2020,EP 10.0 and USP 43,compare the test results obtained using different pharmacopoeias methods and to provide the reference for the improvement of specification of lincomycin hydrochloride.Methods:The chromatographic conditions(column,mobile phase,wavelength,injection volume and flow rate),the preparation methods of test solutions and reference solutions,and criteria in three pharmacopoeias were compared.Results:C_(18) column used in the Chinese Pharmacopoeia 2020 had the good robustness but the sensitivity was lower.EP 10.0 method had the more comprehensive control of impurities,including single impurity,total impurities and three specific impurities.The related substances were not determined inthe USP 43.The contents of lincomycin hydrochloride obtained with 3 different pharmacopoeias were different as calculation on different ingredients.Conclusion:The chromatographic conditions for assay of lincomycin hydrochloride in three pharmacopoeias have some minor differences.However,EP 10.0 method has the comprehensive control of impurities inlincomycin hydrochloride,which can provide an important reference for the revision and improvement of the monograph of lincomycin hydrochloride in the Chinese Pharmacopoeia.