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本文介绍一专属的高压液相层析法测定环磷酰胺原料及注射剂。实验采用微处理机控高压液相层析仪,具可调节体积注射器与可变波长紫外分光检测器,检测器波长200nm,层析往为Lichrosorb C_(18),反相层析柱,25cm×3.2mm。流动相为45%(V/V)甲醇,流速1.0ml/分。原料药与注射用粉针测定时,配制每ml内含主药4.4mg与内标(4-氨基苯甲酸甲酯)0.04mg的供试液与对照液,注入50μl。用内标法计算含量。
This article describes an exclusive high pressure liquid chromatography cyclophosphamide raw materials and injections. Microprocessor-controlled high pressure liquid chromatography with an adjustable volumetric syringe and a variable wavelength ultraviolet spectrophotometer was used in the experiment. The detector wavelength was 200 nm. The chromatographic column was Lichrosorb C 18, reverse phase column, 25 cm × 3.2mm. The mobile phase was 45% (V / V) methanol at a flow rate of 1.0 ml / min. For the raw material medicine and the injection powder for injection, a test solution containing 4.4 mg of the main drug and 0.04 mg of the internal standard (methyl 4-aminobenzoate) per ml was prepared, and 50 μl of the test solution and the control solution were prepared. Use internal standard method to calculate the content.