HPLC法测定氨酚那敏片、维B1那敏片复合包装中维B1那敏片二种成分的含量

Determination of Vitamin B1 and chlorphenamine maleate in comple patching paracetamol and chlorphenamine maleate tablets and vitamin B1 and chlorphenamine maleate tablets by HPLC

目的:建立HPLC法测定氨酚那敏片、维B 1那敏片复合包装中维B 1那敏片(淡橙色片)2种成分的含量。方法:采用Agilent XDB-C18色谱柱(4.6 mm×150 mm,5μm),流动相为辛烷磺酸钠溶液-甲醇-乙腈(57∶25∶18),流速为1.0 mL min^-1,检测波长261 nm。结果:维生素B1在9.75~260.09μg mL^-1范围内线性关系良好(r=0.9998),平均回收率99.40%,RSD为1.70%;马来酸氯苯那敏在2.30~61.45μg mL^-1范围内线性关系良好(r=0.9999),平均回收率100.31%,RSD为1.68%。维生素B 1的含量分别为10.12 mg/片和9.98 mg/片;马来酸氯苯那敏的含量分别为2.10 mg/片和2.00 mg/片。结论:经方法学验证,本法能更真实、有效地用于该制剂的质量控制。

Objective:To establish an HPLC method for determination of two ingredients of Vitamin B1 and Chlorphenamine Maleate Tablets in Complex Patching Paracetamol and Chlorphenamine Maleate Tablets and vitamin B 1 and Chlorphenamine Maleate Tablets.Methods:The assay was performed in an Agilent XDB-C18 column(4.6 mm×150 mm,5μm)under the elution of sodium octanesulfonate solution-methanol-acetonitrile(57∶25∶18).The flow rate was 1.0 mL min^-1 and the detection wavelength was 261 nm.Results:The linear response range of Vitamin B1 fell into 9.75-260.09μg mL^-1,and the average recovery was 99.40%with RSD as 1.70%.The linear response range of chlorphenamine maleate fell into 2.30-61.45μg mL^-1,and the average recovery was 100.31%with RSD as1.68%.The test results of two batches of samples showed that the contents of Vitamin B1 were 10.12 mg and 9.98 mg per tablet,and the contents of chlorphenamine maleat were 2.10 mg and 2.00 mg per tablet.Conclusion:The established method was validated.It can be used for quality control of this preparation effectively.