Quality by design approach to analytical method development for simultaneous estimation of ibuprofen and famotidine in their combined dosage form by RP-HPLC method
Journal Title: International Journal of Research in Pharmacology & Pharmacotherapeutics (IJRPP) - Year 2018, Vol 7, Issue 3
Abstract
This article aims to explain the steps for application of quality by design (QbD) concept to analytical method development and validation, by using an example of simultaneous determination of Famotidine and Ibuprofen in its pharmaceutical dosage form by RP-HPLC. By using QbD tools, enable earlier understanding and identification of variables affecting the method performance. Fractional design and Central composite design were used for screening the variables and optimization of chromatographic conditions with building the design space employing a three factor three level Box– Behnken design (BBD) using ANOVA software. A QbD guide is described from identification of analytical target profile to definition of control strategy. The optimized chromatographic method was performed using 0.01M ammonium acetate buffer (pH 4): methanol: acetonitrile (50:50, 60:40, 40:60, 35:65 % v/v) as mobile phase at a flow rate 1.0mL/ min and UV detection at 225 nm.
Authors and Affiliations
Jayaprakash J
Keywords
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