RP-HPLC法测定氨酚双氢可待因片中对乙酰氨基酚、酒石酸双氢可待因的含量

Determination of paracetarmol and dihydrocodeine tartrate in "paracetamol and dihydrocodeine tartrate tablet" by RP-HPLC

目的建立高效液相色谱法测定氨酚双氢可待因片中对乙酰氨基酚、酒石酸双氢可待因两组分的含量。方法采用双波长测定上述两种成分，采用Hypersil C18 5μ（4．6mm×250mm）（大连依利特公司）色谱柱；乙腈-磷酸盐缓冲液（1％磷酸二氢铵和0．01mol·L^-1辛烷磺酸钠溶液，用磷酸调pH3．0）（15：85）为流动相；检测波长为280nm（对乙酰氨基酚）；209nm（酒石酸双氢可待因）。结果线性范围分别为对乙酰氨基40．192μg·mL^-1～401．92μg·mL^-1。（r=0．9999）、酒石酸双氢可待因0．8359μg·mL^-1～8．3592μg·mL^-1；平均回收率分别为对乙酸氨基酚100．1％（RSD=0．65％）；酒石酸双氢可待因99．4％（RSD=0．33％）。结论本方法精密度好，结果准确可靠，适用于该复方制剂的质量控制。

OBJECTIVE To establish a method of determination of paracetarmol and dihydrocodeine tartrate in ＂Paracetamol and Dihydrocodeine Tartrate Tablet＂ by RP-HPLC. METHODS The chromatographic conditons were as follows;the column was Hypersil C185μ （4. 6mm × 250mm） , the mobile phase consisted a mixture of acetonitrile and a pH3.0 buffer solution （1% NHaH2PO4 ＋ 0. 01mol · L^-1 sodium 1-octanesulfonate） （15：85 ） ;the ultraviolet wavelength was set at 280nm for paracetamol and 209nm for dihydrocodeine tartrate. RESULTS the linear ranges for paracetamol and dihydrocodeine tartrate were 40. 192μg · mL^-1 ～ 401. 92μg · mL^-1 （ r=0. 9999 ） and 0. 8359μg·mL^-1～8. 3592μg·mL^-1（ r = 0. 9995） respectively, The average recoveries for paracetamol and dihydrocodeine tartrate were 100.1% （ RSD = 0.65% ） and 99.4% （ RSD = 0. 33% ） respectively. CONCLUSION The method is accurate and reliable for the quality control of this compound preparation.