QUALITY BY DESIGN APPROACH (QBD) FOR THE SIMULTANEOUS ESTIMATION OF CANDESARTAN CILEXETIL AND AMLODIPINE BESYLATE BY RP–HPLC

A revers phase liquid chromatographic technique has been developed for the separation and determination of candesartan cilexetil and amlodipine besylate using QbD (Quality by Design) approach. The present method was optimised by introducing experimental design approach to identify the chromatographic conditions for adequate separation quality and minimal analysis duration. The relation between independent variables and critical quality attributes is given by experimental design methodology. The separation was achieved on shim-pack solar C18 type column (250 mm × 4.6 mm, 5 µm) as stationary phase; acetonitrile: phosphate buffer pH 6.8 (82:18, v/v); 1.0 ml/min as flow rate; detection wavelength 235 nm. The chromatographic efficiency was investigated for the factorial effect of percentage organic phase and flow rate and finely optimized by employing factorial design experiment. The method was validated and was found to be accurate, precise and robust.