马香苓口服液HPLC的指纹图谱建立

Establishment of fingerprint of Maxiangling oral liquid by HPLC

【目的】建立测定马香苓口服液HPLC的特征指纹图谱.【方法】采用色谱柱phenomenex(Gemini C18110 A:5μm×250 mm×4.60 mm,菲罗门公司);流动相以乙腈∶0.1%甲酸水溶液(V/V)进行梯度洗脱,柱温:35℃;进样量:20μL;流速:0.8 mL/min:紫外吸收波长:300 nm,并进行相似度评价.【结果】对所建立的指纹图谱进行方法学验证,其精密度、重复性、稳定性相对峰面积RSD均小于3.00%,相对保留时间RSD均小于0.20%,相似度计算均大于0.90,符合指纹图谱计算要求;采用《中药色谱指纹图谱相似度评价系统2004 A版》(国家药典委员会)对12批次马香苓口服液HPLC指纹图谱进行相似度计算,与对照指纹图谱的相似度计算结果均大于0.90,且得出18个共有峰是12批次口服液所共有的,表明各批次马香苓口服液之间具有较好的一致性.【结论】该方法准确稳定,科学可行,可以作为该制剂质量评价的指纹图谱研究方法,为其质量标准研究奠定基础.

【Objective】To establish a capillary HPLC fingerprint method of Maxiangling oral liquid.【Method】The chromatographic system was as follows:chromatographic column is phenomenex(Gemini C18110A:5μm×250 mm×4.60 mm,Philomen Company),the acetonitrile and 0.1%formic acid aqueous solution as mobile phase were used gradient elution,the column temperature was 35℃,the injection volume was 20μL,the flow rate was 0.8 mL/min,the detection wavelength was 300 nm,and the similarity of the fingerprint was compared.【Result】We used fingerprint method to carry out methodological verification,RSDs of precision,stability and reproducibility tests were less than 3.00%,the similarity calculation was greater than 0.90,which meeting the requirements of fingerprint calculation.The Similarity Evaluation System for Chromatographic Fingerprint of TCM(2004 A edition)(National Pharmacopoeia Committee)was used to analyze the similarity of 12 batches of Maxiangling oral liquid.The results of similarity calculation with control fingerprint are all greater than 0.90,it is concluded that 18 common peaks are shared by 12 batches of oral liquid.There was good consistency between different batches of Maxiangling oral liquid.【Conclusion】The method is accurate,stable,convenient and feasible.It can be used as a fingerprint method to evaluate the quality of the preparation and lay a foundation for the study of its quality standard.