ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMIFLOXACIN AND AMBROXOL IN SOLID DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 5
Abstract
The present investigation describes about a simple rapid, accurate, precise and reproducible validated reverse phase HPLC method was developed for the determination of Ambroxol and Gemifloxacin in tablet dosage forms. The quantification was carried out using Hypersil BDS HypersilC18(4.6*250mm,3.5 µm,make;ACE) column run in isocratic way using mobile phase comprising of Sodium Phosphate buffer: acetonitrile, in the ratio of 40:60 with a detection wavelength of 246nm, and injection volume of 20µL, with a flow rate of 1.2ml/min. The retention times of the drugs was found to be 3.4min and 2.3min. The linearity ranges of the proposed method lies between 60-140mcg and 7.5-17.5mcg for Gemifloxacin and Ambroxol with correlation coefficient of r2=0.999 and r2=0.998. The assay of the proposed method was found to be 101.22% and 101.92%. The recovery studies were also carried out and % RSD from reproducibility was found to be <2%. LOD and LOQ were found to be 2.93 and 9.91 for Gemifloxacin and 3.0 and 9.97 for Ambroxol respectively. The proposed method was statistically evaluated and can be applied for routine quality control analysis of Gemifloxacin and Ambroxol in bulk and in Pharmaceutical dosage form.
Authors and Affiliations
Md Haseena Begum, Nanda Kishore Agarwal and Duraivel. S
Keywords
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