Abstract

Quality by Design (QbD) approach towards the development and validation of HPLC method for Gentamicin content in biodegradable implants

Author(s): Shrikant Patil, Kari Vijayakrishna and Jaiprakash Sangshetti

A High performance liquid chromatography (HPLC) method for quantitative analysis of Gentamicin is developed using a Quality by Design (QbD) a statistical approach. Gentamicin Sulphate is broad spectrum antibiotic aminoglycoside drug. It is used to treat infections and inflammatory diseases caused by susceptible organisms. Due to regulatory needs QbD has gain magnitude. Foremost target profile is determined and then qualification of instrument is done prior to initiation of actual study. Chromatographic separation is achieved on a C-18 column (250 × 4.6mm, 5micron). The mobile phase used is isocratic elution system consisting of methanol and 15mM di ammonium hydrogen phosphate buffer (pH 10.00) in the ratio 70:30 v/v. In development of HPLC method factors like flow rate, mobile phase composition, column temperature and wavelengths are critical to maintain. Hence Plackett Burman design was used as screening model. Further Box Behnken model was applied as optimization model for the interaction and quadratic effects of three factors namely temperature of the column, flow rate, and wavelength on the selected responses. Effect of these parameters is studied on USP tailing (response). Tailing less than 1.2 was considered as desirable. Results are analyzed using surface diagrams. Verification of the software generated result is done by taking six replicates of the run. Finally the method was validated as per ICH Q2 guidelines. QbD approach is successfully applied for HPLC assay method development of the Gentamicin sulphate.

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