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色谱 2008年第3期26卷 358-361页

作者： SHAHED Mirza NANDA Rabindra DEHGHAN Muhammad Hassan nasreen huda FEROZ Shaikh Maulana Azad Educational Trust’s Y.B.Chavan College of Pharmacy Dr.Rafiq Zakaria CampusRauza BaghAurangabad-431001Maharashtra StateIndia Maulana Azad Educational Trust’s Y.B.Chavan College of Pharmacy Dr.Rafiq Zakaria CampusRauza BaghAurangabad-431001 Maharashtra StateIndia

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.

关键词：氢氯化物高效液体色谱分析分析方法药物剂量

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