川芎嗪衍生物tbn的hplc含量测定方法.docxVIP

Quantitative HPLC Analytical Method for Tetramethylpyrazine Derivative TBNStudent NameMAK SAU HANGStudent No.2005055160MajorPharmacySupervisorProfessor Wang, YuqiangDate(dd/mm/yyyy)25/05/2009 暨 南 大 学本科生毕业论文论文题目 川芎嗪衍生物TBN的HPLC含量测定方法学 院国际学院学 系药学系专 业药学姓 名麦秀珩学 号2005055160指导教师王玉强 教授2008年 5月 25日Statement of OriginalityI hereby declare that the thesis presented is the result of research performed by me personally, under guidance from my supervisor. This thesis does not contain any content (other than those cited with references) that has been previously published or written by others, nor does it contain any material previously presented to other educational institutions for degree or certificate purpose to the best of my knowledge. I promise that all facts presented in this thesis are true and creditable. Signed: _________________ Date：25-05-2009Quantitative HPLC analytical method for tetramethylpyrazine derivative TBNAbstract: A high-performance liquid chromatography (HPLC) method for a new tetramethylpyrazine derivative, TBN, was developed. Analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined under the guideline of International Conference on Harmonization Q2B [1]. TBN was analyzed by RP-HPLC with C18 column using methanol-water (35:65) as mobile phase. The flow rate is 0.8 ml/min and the detector was set to 295 nm. The linearity of calibration curve is good (r2 0.999) and the LOD and LOQ were 12.096 ng/ml and 40.32 ng/ml respectively. The relative standard deviation (RSD) of precision and accuracy were 0.1245 % and 0.6895 %, respectively, and the sample recovery was 99.08 % (RSD: 0.40 %). This method is reliable and easy for TBN analysis. Key Words: tetramethylpyrazine derivative, TBN, HPLC川芎嗪衍生物TBN的HPLC含量测定方法摘 要：目的：建立川芎嗪衍生物 (TBN) 高效液相含量测定方法。方法：选用 C-18 色谱柱；甲醇-水 (35:65)；流速：0.8 ml/min；检测波长为295 nm。结果：TBN 在12.42- 310.5 ?g/ml 范围内线性关系良好 (r2 0.999)