论文部分内容阅读
目的:采用高效液相色谱法测定泮托拉唑钠肠溶片的含量。方法:色谱柱:Hypersil-ODS C_(18)(150mm×4.6mm, 5μm);流动相:乙腈-磷酸盐缓冲溶液(用磷酸氢二钠1.12g和磷酸二氢钠0.18g加水1000 ml调pH至7.6)(30:70);流速: 1.0ml·min~(-1),检测波长:288nm;柱温:室温。结果:泮托拉唑钠在12～120μg·ml~(-1)浓度范围内,呈良好的线性关系(r= 0.999 96),平均回收率为99.7%,RSD=0.12%(n=6)。结论:方法简便、可靠、快速、可用于泮托拉唑钠肠溶片生产的质量控制。
Objective: To determine the content of pantoprazole sodium enteric-coated tablets by high performance liquid chromatography. METHODS: The chromatographic column was Hypersil-ODS C 18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-phosphate buffer (1.12 g with sodium hydrogen phosphate and 0.18 g with sodium dihydrogen phosphate, To 7.6) (30:70); flow rate: 1.0 ml · min -1, detection wavelength: 288 nm; column temperature: room temperature. Results: Pantoprazole sodium had a good linear relationship (r = 0.999 96) with an average recovery of 99.7% and a RSD of 0.12% (n = 6) in the range of 12 ~ 120μg · ml ~ . Conclusion: The method is simple, reliable and rapid and can be used for the quality control of pantoprazole sodium enteric-coated tablets.