高效液相色谱法测定复方氯唑沙宗片中两组分血药浓度

Determination of two component concentrations of complex chlorzoxazone tablets in human serum by HPLC

目的:研究建立测定血浆中复方氯唑沙宗片两组分浓度的HPLC-UV法。方法:反相高效液相色谱法测定血浆中药物的浓度。Zorbax XDB-C18色谱柱,血浆样品经乙醚提取,空气吹干,加流动相溶解进样。氯唑沙宗的流动相为甲醇∶水=(60∶40),在波长282nm处检测;对乙酰氨基酚的流动相为甲醇∶水=(20∶80),在波长245nm处检测,以外标法计算。结果:氯唑沙宗在0.208～33.28μg/ml、对乙酰氨基酚在0.238～14.28μg/ml浓度范围内,样品的峰面积与对应浓度呈良好线性关系,r氯=0.9998,r对=0.9998。最低检测限均为0.1μg/ml,氯唑沙宗高、中、低(20.8μg/ml,4.16μg/ml,0.416μg/ml)3种浓度的方法回收率分别为(103.36±6.0)%,(99.51±1.2)%,(99.08±1.88)%;对乙酰氨基酚高、中、低(9.52μg/ml,2.38μg/ml,0.476μg/ml)3种浓度的方法回收率依次为(101.5±3.15)%,(97.6±1.93)%,(99±3.15)%,日内RSD分别为(1.2%～2.3%)、(1.4%～6.7%),日间RSD分别为(2.5%～5.1%)、(5%～7.8%)。结论:此法操作简便、结果可靠。

Objective：To establish a HPLC method for the determination of two component concentrations of complex chlorzoxazone tablets in human serum.Methods：The serum samples were extracted with ether,dried with gas,dissolved in mobile phase and determined with HPLC. The Zorbax XDB-C18 column was used. The mobile phase consisted of methanol：water （60：40）or methanol：water （20：80） respectively. It was detected at 282 nm or 245nm respectively.Results：A hnearity was obtained from 0.208 to 33.28 μg/ml of chlorzoxazone （r=0.9998） and from 0.238 to 14.28 μg/ml of acetaminophen （r = 0.9998） respectively. The limit of detection was 0.1 μg/ ml. Their average recoveries were 95.3% and 99.4% respectively. The precision （RSD） was 6.0% and 2.4% respectively. Conclusion： This study provided a simple and reliable assay which can be used to determine two component concentrations of complex chlorzoxazone tablets in human serum.