高效液相色谱法测定复方氯唑沙宗片的有关物质___

 

 

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 C₁₈柱（4.6 mm×250 mm，5 μm），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至3.0）-乙腈-四氢呋喃（47.5∶47.5∶5），流速为0.5 mL·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，5 μm）,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.

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6ZHANG Dong-mei （张冬梅），CHEN Qiu-fen（陈秋芬）.Determination of Related Substances in Paracetamol and Tramadol Hydrochloride Orally Disintegrating Tablets by HPLC （氨酚曲马多口腔崩解片中有关物质的HPLC测定）. Chin J Pharm（中国医药工业杂志），2007，38（1）：36

7CHEN Zhu-kang （陈祝康），PENG Xing-sheng（彭兴盛）.Determination of Jiere Zhitong Powder by HPLC （解热止痛散中三组分含量及有关物质的HPLC测定）.Chin J Pharm（中国医药工业杂志），2003，34（6）：288