反相高效液相色谱法同时测定片剂中的加替沙星与盐酸氨溴索(英文)

作     者：SHAHED Mirza NANDA Rabindra DEHGHAN Muhammad Hassan NASREEN Huda FEROZ Shaikh 

作者机构：Maulana Azad Educational Trust’s Y.B.Chavan College of PharmacyDr.Rafiq Zakaria CampusRauza BaghAurangabad-431001Maharashtra StateIndia Maulana Azad Educational Trust’s Y.B.Chavan College of PharmacyDr.Rafiq Zakaria CampusRauza BaghAurangabad-431001 Maharashtra StateIndia 

出 版 物：《色谱》 (Chinese Journal of Chromatography)

年 卷 期：2008年第26卷第3期

页      面：358-361页

核心收录：

学科分类：0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 081704[工学-应用化学] 07[理学] 0817[工学-化学工程与技术] 08[工学] 070305[理学-高分子化学与物理] 080501[工学-材料物理与化学] 0805[工学-材料科学与工程（可授工学、理学学位）] 0703[理学-化学] 10[医学] 

主　　题：氢氯化物 高效液体色谱分析 分析方法 药物 剂量 

摘      要：A reversed-phase high performance liquid chromatography (HPLC) method was developed, validated, and used for the quantitative determination of gatifloxacin (GA) and ambroxol hydrochloride (AM), from its tablet dosage form. Chromatographic separation was performed on a HiQ Sil C18 column (250 mm×4.6 mm, 5 μm), with a mobile phase comprising of a mixture of 0.01 mol/L potassium dihydrogen orthophosphate buffer and acetonitrile (70∶30, v/v), and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 1 mL/min, with detection at 247 nm. Separation was completed in less than 10 min. As per International Conference on Harmonisation (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, and robustness. Linearity of GA was found to be in the range of 10-60 μg/mL and that for AM was found to be 5-30 μg/mL. The correlation coefficients were 0.999 6 and 0.999 3 for GA and AM respectively. The results of the tablet analysis (n=5) were found to be 99.94% with ±0.25% standard deviation (SD) and 99.98% with±0.36% SD for GA and AM respectively. Percent recovery of GA was found to be 99.92%-100.02% and that of AM was 99.86%-100.16%. The assay experiment shows that the method is free from interference of excipients. This demonstrates that the developed HPLC method is simple, linear, precise, and accurate, and can be conveniently adopted for the routine quality control analysis of the tablet.