高效液相色谱法测定注射用匹多莫德中匹多莫德含量.docVIP

高效液相色谱法测定注射用匹多莫德中匹多莫德含量[摘要] 目的:建立高效液相法测定注射用匹多莫德中匹多莫德含量的方法。方法:采用Diamonsil-C18(4.6 mm×250 mm,5 μm)色谱柱;流动相:0.01 mol/L NaH2PO4-甲醇-水(97∶2∶1)(磷酸调节pH至pH=2.5);检测波长:210 nm;流速:1.0 ml/min。结果:匹多莫德在0.273 2～4.371 2 μg范围内与峰面积呈良好的线性关系(r=0.999 7),平均回收率为99.66%,RSD=0.80%(n=6)。结论:本方法简便、准确、重现性好,可用于注射用匹多莫德中匹多莫德的质量控制。 [关键词] 高效液相法;匹多莫德;注射用匹多莫德;含量测定 [中图分类号] R927.2[文献标识码] B[文章编号] 1673-7210(2010)04(a)-088-02 Content determination of pidotimod and its related substances in Pidotimod for Injection by HPLC LIU hong1, MAO Ling2 (1.Department of Pharmaceutics, the People’s Hospital of Tonghua, Tonghua 134001, China; 2. Department of Pharmaceutics, the People’s Hospital of Nanjing, Nanjing 211500, China) [Abstract] Objective: To establish a method for the content determination of pidotimod in Pidotimod for Injection by HPLC. Methods: The Diamonsil-C18 (4.6 mm×250 mm, 5 μm) column was used. The mobile phases consisted of 0.01 mol/L-sodium dihydrogen phosphate dihydrate, methanol and water (97∶2∶1) (adjust pH to pH=2.5 by phosphoric acid), the flow rate was 1.0 ml/min and the detection wavelength was at 210 nm. Results: The linear ranges of pidotimod was at 0.273 2-4.371 2 μg (r=0.999 7), the average recovery was 99.66% with a RSD of 0.80% (n=6). Conclusion: The method is fast, reliable, accurate and can be used in the quality control of pidotimod in Pidotimod for Injection. [Key words] HPLC; Pidotimod; Pidotimod for Injection; Content determination 匹多莫德首先由意大利Poli化学工业公司研制开发,1993年上市并进入临床应用,是一种人工合成的免疫刺激剂,虽无直接杀菌及抗病毒作用,但可增强特异性及非特异性免疫功能[1]。目前国内上市的匹多莫德的剂型主要有口服溶液、颗粒剂、片剂等,但还没有匹多莫德注射液及冻干粉针。笔者采用高效液相色谱法测定注射用匹多莫德中的匹多莫德的含量,方法准确、高效、简便、快速。 1 仪器与试药 1.1 仪器 岛津LC-10AT泵,岛津SPD-10A紫外检测器;HW-2000色谱工作站。 1.2 试药 匹多莫德对照品(批号:100588-200501,含量:100%,中国药品生物制品检定所);匹多莫德对照品(批号:100588-200501,含量:100%,南京威尔曼药物研究所);磷酸二氢钠为分析醇;甲醇、异丙醇均为色谱纯。 2 方法与结果 2.1 色谱条件 色谱柱:Diamonsil-C18(4.6 mm×250 mm,5 μm);流动相:0.01 mol/L NaH2PO4-甲醇-水(97∶2∶1)(磷酸调节pH至pH=2.5);检测波长:210 nm;流速:1.0 ml/min。柱温:室温;进样量:20 μl;理论塔板数按匹多莫德