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机构地区:[1]河南省周口市食品药品检验所,河南周口466000
出 处:《中国药业》2011年第24期46-47,共2页China Pharmaceuticals
摘 要:目的建立测定硫酸阿托品注射液含量的反相高效液相色谱法。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为0.05 mol/L磷酸二氢钾溶液(含0.002 5 mol/L庚烷磺酸钠,用氢氧化钠试液调节pH至5.0)-乙腈(82∶18),流速为0.8 mL/min,检测波长为225 nm。结果硫酸阿托品进样量在1.002 4~10.024μg范围内与峰面积线性关系良好(r=0.999 75),平均回收率为99.81%,RSD为0.79%(n=6)。结论该方法简便、快速,结果准确,适用于硫酸阿托品注射液的质量控制。Objective To establish a HPLC method for determining the content of Atropine Sulfate Injection. Methods The RP- HPLC method was adopted. The column was Kromasil C~ column (250mm×4.6mm,5μm),the mobile phase was 0.05 mol/L potassium dihydrogen phosphate solution (containing 0. 002 5 mol/L heptane sodium sulfonate)-acetonitrile(82 : 18) (adjusting pH 5.0 with sodium hydroxide solution), the flow rate was 0.8 mL/min and the detection wavelength was 225 nm. Results The linear range was 1. 002 4- 10. 024 μg( r = 0. 999 75). The average recovery rate was 99.81%, RSD = 0.79% (n = 6). Conclusion The method is simple,rapid,accurate and suitable for the quality control of Atropine Sulfate Injection.
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