摘要
目的:建立反相HPLC法测定注射用甲泼尼龙琥珀酸钠主药及游离甲泼尼龙的含量。方法:采用Kromasil(250 mm×4.6 mm,5μm)色谱柱,以甲醇-10 mmol·L^(-1)醋酸铵缓冲液(以冰醋酸调pH至5.3)(55:45)为流动相,流速:1.0 ml·min,检测波长:245 nm,柱温:35℃,进样体积:20μl。结果:琥珀酸甲泼尼龙在0.011 76～0.705 6 mg·ml^(-1)l浓度范围内呈良好线性关系(r=0.999 9);平均回收率为98.2%,RSD为0.3%(n=9);游离甲泼尼龙在0.002 62～0.026 2 mg·ml^(-1)l浓度范围内呈良好线性关系(r=0.999 9);平均回收率为96.5%,RSD为0.8%(n=9)。结论:本法简便、准确、重复性好,可用于注射用甲泼尼龙琥珀酸钠的质量控制。
Objective：To develop an HPLC method for the determination of methylprednisolone sodium succinate and free methylprednisolone in methylprednisolone sodium succinate for injection.Method：A Kromasil column（250 mm×4.6 mm,5μm） was adopted with the mobile phase of methanol-10 mmol？L^（-1） ammonium acetate buffer（adjusting pH to 5.3 with acetic acid）（55：45） at the flow rate of 1.0 ml？min^（-1）.The detection wave length was 245 nm,the column temperature was 35℃and the injection volume was 20μl.Result：A good linear correlation of methylprednisolone hemisuccinate and free methylprednisolone were observed within the range of 0.011 76-0.705 6 mg？ml^（-1）（r=0.9999） and 0.00262-0.0262 mg？ml^（-1）（r=0.9999） with the average recovery of 98.2% （RSD=0.3%,n=9） and 96.5%（RSD=0.8%,n=9）,respectively.Conclusion：The method is simple,accurate and repealable, and can be used in the quality control of methylprednisolone sodium succinate for injection.
出处
《中国药师》
CAS
2013年第8期1164-1166,共3页
China Pharmacist
