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目的:建立甲泼尼龙琥珀酸钠注射液含量以及有关物质的反相高效液相色谱检测方法。方法:采用Zorbax-XDB-C18柱(100 mm×46.mm,5μm),流动相为0.66%四丁基氢氧化铵溶液(磷酸调pH至6.5)-乙腈(3:2),流速1.0 mL·min-1,检测波长为254 nm。结果:甲泼尼龙琥珀酸在100～900μg·mL-1浓度范围内线性关系良好(r=1.0000),高、中、低3种不同浓度的回收率分别为100.7%,100.5%,100.7%,定量限0.5μg·mL-1,游离甲泼尼龙在10-50μg·mL-1浓度范围内线性关系良好(r=1.0000),高、中、低3种不同浓度回收率分别为100.5%,100.6%,100.3%,检测限0.05μg.mL-1。结论:本方法将现有的正相色谱法改进为反相色谱法。操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。
Objective: To establish a method for the determination of methylprednisolone sodium succinate injection and its related substances by RP-HPLC. Methods: Zorbax-XDB-C18 column (100 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.66% tetrabutylammonium hydroxide (adjusted to pH 6.5 with phosphoric acid) -1, the detection wavelength is 254 nm. Results: The calibration curve of methylprednisolone succinate showed good linearity (100.00%, 100.5%, 100.7%, 100.7%, 100%) at the concentrations of 100-900μg · mL-1 The limit of quantification was 0.5μg · mL-1. The free methylprednisolone had a good linearity (r = 1.0000) in the concentration range of 10-50μg · mL-1. The recoveries of high, medium and low concentrations were 100.5%, 100.6% %, 100.3%, detection limit 0.05μg.mL-1. Conclusion: This method improves the existing normal phase chromatography to reverse phase chromatography. Easy to operate, good precision, the results are accurate and reliable, can be used for the quality control of the preparation.