RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF GATIFLOXACIN AND AMBROXOL HCL IN PHARMACEUTICAL DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 4
Abstract
Objective: To develop a simple, selective, linear, precise and accurate RP-HPLC method for simultaneous estimation of Gatifloxacin and Ambroxol HCl in tablet dosage form.Methods: The chromatographic separation was performed using Inerstil ODS-3V (4.6 x 250 mm, 5 µm particle size). Mobile phase was composed of phosphate Buffer pH-5 and methanol (40:60v/v) at a flow rate of 1 ml/min. Detection was carried out using PDA detector at 237 nm. The method was validated as per ICH guidelines.Results: The retention times for Gatifloxacin and Ambroxol HCl were observed as 2.443 and 4.863 min respectively. Linearity range was observed in concentration of 32-112 µg/ml for Gatifloxacin and 6-21 µg/ml for Ambroxol HCl. The percentage recoveries of Gatifloxacin and Ambroxol HCl are 99.64% and 99.78% respectively. The correlation coefficients for both the components are close to 1.Conclusion: This method is simple, selective, linear, precise, accurate and sensitive hence can be successfully employed for the routine quality control of dosage forms containing both the drugs in pharmaceutical industries.Â
Authors and Affiliations
Saroj Kumar Raul, Bainapalli Shanmukha, Durgasi Jhansi
Keywords
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