摘要
目的 基于高效液相色谱法(HPLC)建立TALICA缓释胶囊中阿莫西林、奥美拉唑镁、利福布汀3种主成分和葡甲胺辅料的含量.方法 应用HPLC法,色谱柱为Agilent Zorbax SB-C18 柱(150 mm×4.5 mm,5 μm);流动相分别为乙腈(A)-磷酸盐缓冲液(B)和乙腈(A)-庚烷磺酸钠缓冲液(B),按时间程序梯度洗脱;VWD检测器,检测波长分别为254 nm和195 nm;进样量分别为10 μL和20 μL;流速均为1 mL·min-1;柱温分别为26℃和35℃;通过外标法计算阿莫西林、奥美拉唑镁、利福布汀3种主成分和葡甲胺辅料的含量.结果 在波长254 nm下,阿莫西林、奥美拉唑镁、利福布汀分别在质量浓度0.02～2.12、0.02～2.16、0.02～2.16 mg·mL-1内线性关系良好(r均大于0.999 7),平均回收率分别为99.5%、98.9%、99.6%,RSD 分别为 0.5%、1.1%和 0.6%,测得 3 种主成分的标示百分含量范围为98.8～101.1%.在波长195 nm下,葡甲胺在质量浓度1.00～50.00 mg·mL-1内线性关系良好(r为0.999 9),平均回收率及RSD为100.8%、0.9%,测得葡甲胺的平均含量为6.6%.结论 HPLC法建立的TALICA缓释胶囊中阿莫西林、奥美拉唑镁、利福布汀3 种主成分和葡甲胺辅料的含量测定分析方法稳定、简单、可靠,可用于TALICA缓释胶囊的质控研究.
Abstract
Objective To set up the content of three principal components of amoxicillin,omeprazole magnesium,rifabutin and meglumine in TALICA sustained release capsules based on high performance liquid chromatography(HPLC).Methods By applying HPLC method,the Agilent ZORBAX SB-C18 chromatographic column(150 mm×4.5 mm,5 μm)was used.The mobile phases were acetonitrile(A)-phosphate buffer(B)and acetonitrile(A)-heptane sodium sulfonate buffer(B),respectively,and the elution was gradient according to a time program.Using VWD detector,the detection wavelengths were 254 nm and 195 nm,respectively.Injection volume was 10 μL and 20 μL,respectively.The flow rate was 1 mL·min-1.The column temperatures were 26℃and 35℃,respectively.By external standard method,the content of three principal components of amoxicillin,omeprazole magnesium,rifabutin and meglumine excipients was calculated.Results At 254 nm,there was a good linear relationship between amoxicillin,omeprazole magnesium,and rifabutin in the mass concentrations of 0.02-2.12,0.02-2.16,0.02-2.16 mg·mL-1,respectively(r>0.999 7).The average recoveries were 99.5%,98.9%and 99.6%,and RSD were 0.5%,1.1%and 0.6%,respectively.The mark percentage content of the three principal components were 98.8%-101.1%.At 195 nm,meglumine showed a good linear relationship within the mass concentration of 1.00-50.00 mg·mL-1(r=0.999 9).The average recovery and RSD were 100.8%and 0.9%,and the average content of meglumine was 6.6%.Conclusion The HPLC method for the determination and analysis of the content of amoxicillin,omeprazole magnesium,rifabutin and meglumine in TALICA sustained release capsules is stable,straightforward and dependable,which can offer the basis for the study of quality control of TALICA sustained release capsules.
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