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采用高效液相色谱法,建立药品生产企业检测中心快速、有效测定注射用奥美拉唑钠粉针药效成分含量的方法。色谱柱:Nobel Kromasil C8色谱柱(250 mm×4.6 mm,5μm);柱温:25℃;流动相:0.01mol/L V[磷酸一氢钠溶液(用磷酸调节pH值至7.6)]∶V(乙腈)=75∶25;流速:1.0mL/min;检测波长:280nm。该方法样品前处理简单、精密度高、准确可靠,能够满足药品生产企业对注射用奥美拉唑钠粉针药效成分含量检测要求,操作简捷易行,适合于注射用奥美拉唑钠粉针的质量控制。
Using high-performance liquid chromatography to establish a rapid and effective method for the determination of the content of the omeprazole sodium powder injection in the testing center of pharmaceutical manufacturing enterprises. Column: Nobel Kromasil C8 column (250 mm × 4.6 mm, 5 μm); column temperature: 25 ° C .; mobile phase: 0.01 mol / LV [sodium phosphate monobasic phosphate solution adjusted to pH 7.6 with phosphoric acid] Acetonitrile) = 75:25; flow rate: 1.0 mL / min; detection wavelength: 280 nm. The method has the advantages of simple pretreatment sample, high precision, accuracy and reliability, and can meet the requirements of the pharmaceutical manufacturing enterprises for the detection of the active ingredient content of the omeprazole sodium powder injection for injection. The method is simple and easy to operate and is suitable for omeprazole sodium for injection Quality control of powder.