高效液相色谱法测定复方氯唑沙宗片的有关物质

HPLC determination of related substances of compound chlorzoxazone tablets

目的:建立复方氯唑沙宗片中有关物质的HPLC检测方法。方法:采用Agilent Eclipse C_(18)柱(4.6 mm×250 mm,5μm),流动相为25 mmol·L^(-1)磷酸二氢钾缓冲液(用10%磷酸溶液调节pH值至3.0)-乙腈-四氢呋喃(47.5:47.5:5),流速为0.5mL·min^(-1),检测波长为280 nm,柱温30℃。结果:主成分对乙酰氨基酚和氯唑沙宗与各有关物质分离度良好,4种已知杂质对氨基酚、对氯苯乙酰胺、对氯苯酚和2-氨基-4-氯苯酚在各自的浓度范围内均有良好的线性关系,相关系数均在0.9999以上,平均回收率均在95.3%和105.7%范围内,RSD在0.4%和3.6%之间,最低检测限均在0.9 ng和1.2 ng之间。结论:方法简便、可靠、灵敏度高,可用于质量控制。

Objective：To establish an RP - HPLC method for the determination of related substances of compound chlorzoxazone tablets.Methods：The chromatographic column was Agilent Eclipse C18（4.6 mm×250 mm,5μm）, the mobile phase consisted of a mixture of 25 mmol·L^-1 potassium dihydrogen phosphate buffer（adjust pH to 3.0 with 10%phosphoric acid solution） - acetonitrile - tetrahydrofuran（47.5：47.5：5）.The flow rate was 0.5 mL·min^-1 and the detection wavelength was 280 nm.The column temperature was maintained at 30℃.Results：Paracetamol and chlorzoxazone and their related substances were separated well.The calibration curves of four known related substances,4 - aminophenol,4＇ - chloroacetanilide,p- chlorophenol and 2 - amino -4 - chlorophenol were linear within the concentration range measured,the average recoveries were between 95.3%and 105.7%,the RSDs were between 0.4%and 3.6%,and LODs were between 0.9 ng and 1.2 ng.Conclusion：The method is simple,reliable, specific,and can be used for the quality control of compound chlorzoxazone tablets.